[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diarrhea\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diarrhea":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,57,91,120,147,172,219,257,285,310,335,357,381,407,433,462,484,509,531,556,580,605,627,654,680],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100643888","glp-1-receptor-agonists-and-early-proctologic-effects-in-morbid-obesity-100643888",false,"NCT07668765","GLP-1 Receptor Agonists and Early Proctologic Effects in Morbid Obesity","Early Proctologic Effects of GLP-1 Receptor Agonist Therapy in Morbidly Obese Patients: A Prospective Cohort Study With Baseline and 3-Month Proctologic Assessment","GLP-PROCT","Inclusion Criteria:\n\n* Age ≥18 years\n* Morbid obesity (BMI ≥40 kg\u002Fm² or BMI ≥35 kg\u002Fm² with obesity-related comorbidities)\n* Newly prescribed GLP-1 receptor agonist therapy\n* Ability and willingness to provide written informed consent\n* Ability to attend 3-month follow-up visit\n\nExclusion Criteria:\n\n* Inflammatory bowel disease\n* Perianal Crohn's disease\n* History of anorectal malignancy\n* Previous pelvic radiotherapy\n* Anorectal surgery within the previous 3 months\n* Pregnancy\n* Neurogenic bowel dysfunction\n* Inability to comply with follow-up visits\n* Discontinuation of GLP-1 receptor agonist therapy before follow-up assessment\n* Active anorectal infection or abscess","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","3 Months","OBSERVATIONAL","Prospective observational cohort study evaluating the early proctologic effects of GLP-1 receptor agonist therapy in morbidly obese patients. Participants will undergo baseline and 3-month anorectal symptom assessment and proctologic examination to evaluate newly developed proctologic diseases and changes in pre-existing symptoms.",[26,27,28,29,30],"Morbid Obesity","Anorectal Diseases","Drug-Related Side Effects and Adverse Reactions","Constipation","Diarrhea",[32,33,34,35,36,37,38,39,40,41,42,43],"GLP-1 receptor agonist","obesity","anorectal symptoms","hemorrhoids","anal fissure","constipation","semaglutide","tirzepatide","proctologic examination","bowel habits","anorectal disease","proctology","NOT_YET_RECRUITING","2026-06-23",{"date":47,"type":48},"2026-06-25","ACTUAL",{"date":50,"type":21},"2026-08",{"date":52,"type":21},"2027-05",{"name":54,"class":55},"Gazi University","OTHER",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":68,"conditions":69,"keywords":74,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":56},"100640255","balanced-crystalloid-vs-normal-saline-in-pediatric-acute-gastroenteritis-100640255","NCT07610382","Balanced Crystalloid vs Normal Saline in Pediatric Acute Gastroenteritis","Comparison of Early Biochemical and Clinical Outcomes of Balanced Versus Unbalanced Isotonic Crystalloid in Children Aged 6 Months to 5 Years Who Require Intravenous Rehydration for Acute Gastroenteritis: A Single-Center Prospective Observational Cohort Study","Inclusion Criteria:\n\n* Age: 6 months to 5 years (60 months) inclusive\n* Clinical diagnosis of acute gastroenteritis: acute diarrhoea (3 or more loose stools per 24 hours) with or without vomiting; symptom duration 7 days or less\n* Clinician-initiated indication for intravenous rehydration\n* IV fluid order placed and treatment initiated independently by the treating physician, without research team influence\n\nExclusion Criteria:\n\n* Chronic systemic disease (congenital heart disease, chronic kidney disease, chronic lung disease, inborn errors of metabolism, primary immunodeficiency)\n* Hypernatraemic dehydration (serum sodium \\>= 150 mEq\u002FL at baseline)\n* Diabetic ketoacidosis, primary metabolic crisis, or suspected surgical abdomen\n* Bloody diarrhoea or suspected invasive enteric infection requiring alternative management algorithm\n* Hypoglycaemia (blood glucose \\\u003C 60 mg\u002FdL) at presentation\n* Symptom duration exceeding 7 days\n* Receipt of 20 mL\u002Fkg or more of IV fluid in the 24 hours preceding enrolment","6 Months","5 Years",{"count":67,"type":21},180,"Acute gastroenteritis (AGE) is among the most common reasons for paediatric emergency visits. Children with significant dehydration often require intravenous (IV) fluid therapy. Two main types of IV crystalloid solutions are currently used in clinical practice: 0.9% sodium chloride (normal saline, NS) and balanced crystalloids such as Isolyte-S, which contain acetate and gluconate as bicarbonate precursors.\n\nNormal saline has a high chloride content (154 mEq\u002FL), which may worsen the metabolic acidosis already present in many children with acute gastroenteritis. Balanced crystalloids have a chloride content closer to that of plasma (98 mEq\u002FL) and additionally contain acetate and gluconate, which are metabolised in peripheral tissues to consume hydrogen ions and thereby raise serum bicarbonate - a mechanism distinct from simply avoiding chloride overload.\n\nThis study prospectively observes and compares early biochemical and clinical outcomes in children with acute gastroenteritis who receive one of these two fluid types as part of their routine clinical care. The treating physician independently decides which fluid to use; the research team does not influence this decision and does not order any additional tests or procedures. Laboratory values used as outcomes are drawn solely from blood tests obtained as part of standard care.\n\nThe primary aim is to determine whether, at approximately 4 hours after IV fluid start, serum bicarbonate has changed more in children who received a balanced crystalloid compared with those who received normal saline. Secondary aims include comparing blood pH, chloride levels, need for additional IV boluses, time to first oral fluid intake, hospitalisation rate, and 72-hour return visits.",[70,71,72,30,73],"Gastroenteritis Acute","Dehydration","Acidosis, Metabolic","Vomiting",[75,76,77,78,79,80,71],"balanced crystalloid","normal saline","bicarbonate","metabolic acidosis","pediatric emergency","Acute Gastroenteritis","RECRUITING","2026-05-22",{"date":84,"type":48},"2026-05-28",{"date":86,"type":48},"2026-05-15",{"date":88,"type":21},"2027-03",{"name":90,"class":55},"Aydin Adnan Menderes University",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":17,"minAge":99,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100637193","evaluating-in-line-chlorination-in-nigeria-100637193","NCT07601503","Evaluating In-line Chlorination in Nigeria","In-line Chlorination for Drinking Water Treatment in Nigeria","Inclusion Criteria:\n\n* Adult (18+) or emancipated minor (15+) pregnant women and women with children under 5 years old who do not plan to permanently move in the next 12 months.\n* Must be knowledgeable about the household's water collection and management practices\n\nExclusion Criteria:\n\n* Non-age-eligible women. Men and non-emancipated minors. Women who do not consent.",true,"15 Years",{"count":101,"type":21},2655,"INTERVENTIONAL",[104],"NA","This study evaluates the implementation and effectiveness of in-line chlorination (ILC) for improving drinking water quality in rural Nigeria. Unsafe drinking water remains a major contributor to diarrheal disease, particularly among children under five. Inline chlorination is a passive water treatment approach that automatically doses chlorine at community water systems without requiring electricity or daily user action. Two cluster randomized controlled trials will be conducted in Kano State (North-West Nigeria) and Cross River State (South-South Nigeria). Communities will be randomized to either receive in-line chlorination installed at eligible communal water systems or serve as controls with no chlorination. The unit of randomization is a community or a cluster of communities that share water system for drinking water. The primary objective is to estimate the causal impact of in-line chlorination on household drinking water quality. Outcomes include the prevalence of Escherichia coli contamination in tap water and stored household water as well as the presence of free chlorine residual. Secondary objectives assess water source usage and adoption of chlorinated sources, as well as reduction in diarrheal disease. Implementation fidelity and operational performance of chlorination devices will also be monitored.",[30,107,108],"Water Quality","Adoption",[110],"Inline Chlorination, Safe Water, Water Practices, Behavior, Diarrhea, Children","2026-05-14",{"date":82,"type":48},{"date":114,"type":21},"2026-05-26",{"date":116,"type":21},"2027-12-31",{"name":118,"class":55},"University of California, Berkeley",2,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":102,"phases":131,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":146},"100634905","phase-2-a-study-of-brenipatide-ly3537031-in-participants-with-irritable-bowel-syndrome-diarrhea-ibs-d-100634905","NCT07545759","A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants With IBS-D","RENEW-IBS-D","Inclusion Criteria:\n\n* Meet Rome IV criteria for IBS-D, which includes having greater than 25% of bowel movements with Bristol Stool Form Scale (BSFS) Types 6 or 7 and \\\u003C25% of bowel movements with BSFS Types 1 or 2\n* Based on the daily eDiary collection during the screening period:\n\n  * Have average of worst abdominal pain score of ≥3.0 on a 0-to-10-point scale during the 14 consecutive days prior to randomization\n  * Have at least 4 days per week with a maximum BSFS ≥5 AND with at least 2 days of the 4 days per week with a maximum BSFS ≥6 during the 14 consecutive days prior to randomization\n* Have had no major changes in diet in the 4 weeks prior to screening\n\nExclusion Criteria:\n\n* Have a diagnosis of IBS with a subtype of constipation, mixed IBS, or unclassified IBS by the Rome IV criteria\n* Have a history of inflammatory or immune-mediated gastrointestinal disorders\n* Have a known clinically significant gastric emptying abnormality","75 Years",{"count":130,"type":21},531,[132],"PHASE2","The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo.\n\nThe study will last approximately 35 weeks.",[135,30],"Irritable Bowel Syndrome","2026-05-11",{"date":138,"type":48},"2026-05-13",{"date":140,"type":48},"2026-05-06",{"date":142,"type":21},"2027-11",{"name":144,"class":145},"Eli Lilly and Company","INDUSTRY",88,{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":154,"minAge":18,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":102,"phases":158,"briefSummary":159,"conditions":160,"keywords":161,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":56},"100498950","phase-2-fecal-microbiota-transplantation-for-ibs-100498950","NCT05776914","Fecal Microbiota Transplantation for IBS","Efficacy and Safety of Proteolytic Activity-Guided Fecal Microbiota Transplantation for Irritable Bowel Syndrome (PRAGMAT Trial)","Inclusion Criteria:\n\n* IBS defined by Rome IV criteria\n* Non IBS-C\n* Moderate to severe symptoms defined by IBS-SSS≥175\n* Able to safely undergo and consent to colonoscopy\n\nExclusion Criteria\n\n* Immune deficiency or treatment with immunosuppressive medications\n* Severe bowel or medical disease precluding administration of bowel prep\n* Severe bowel or medical disease precluding colonoscopy with conscious sedation\n* Active cancer\n* Pregnant or lactating\n* Abdominal surgery (exception of splenectomy, partial hepatectomy, partial\u002Funilateral nephrectomy, laparoscopy, pelvic floor repair, mesh, liposuction, fundoplication, tubal ligation, gastric sleeve, oophorectomy, hernia, appendectomy, cholecystectomy, caesarean section and hysterectomy)\n* Severe psychiatric disorder (HADS-A or D\\>16), or diagnosed alcohol or drug abuse disorder\n* New probiotics or treatment with antibiotics, NSAIDs (within 4 wks prior to study entry)\n* Use of treatments known to affect colonic motility (with exception of loperamide)\n* Diagnosed h\u002Fo bleeding disorder\n* Organic GI diseases (IBD, celiac disease, microscopic colitis)\n* Chronic kidney or liver disease\n* Absolute neutrophil count (ANC) \\\u003C500 IU\u002Fml","FEMALE","70 Years",{"count":157,"type":21},43,[132],"The purpose of this study is to learn the efficacy and safety of fecal microbiota transplantation (FMT) using stool from a donor with low proteolytic activity and containing the bacteria Alistipes putredinis in patients with irritable bowel syndrome (IBS) and high proteolytic activity. Proteolytic activity is the breakdown of proteins into smaller polypeptides or amino acids.",[135,30],[162,163],"Post-infection irritable bowel syndrome with diarrheal","Post-infection irritable bowel syndrome with mixed symptoms",{"date":165,"type":48},"2026-05-08",{"date":167,"type":48},"2024-04-15",{"date":169,"type":21},"2027-06-26",{"name":171,"class":55},"Madhusudan (Madhu) Grover, MBBS",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":154,"minAge":180,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":102,"phases":183,"briefSummary":184,"conditions":185,"keywords":202,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":56},"100636706","improved-child-nutrition-and-development-through-social-transfers-100636706","NCT07569172","Improved Child Nutrition and Development Through Social Transfers","Taabo Enhanced Nutrition and Development Through Economic Rewards","TENDER","Inclusion Criteria:\n\n1. Are enrolled in the Taabo multigenerational birth cohort (MGC)\n2. Completed the postpartum interview of the Taabo MGC\n3. Have a child who is within two weeks of their 12-month birthday,\n4. are breastfeeding at time of recruitment,\n5. live in the Taabo HDSS, Côte d'Ivoire\n6. have no illnesses that contraindicates breastfeeding,\n7. had a healthy singleton infant with a birth weight of at least 2500 grams, and\n8. agree to participate and sign an informed consent; if underage (12-17 years), a legal representative will also have to agree to sign the informed consent\n\nExclusion Criteria:\n\n1. Plans to move permanently outside study area\n2. Has a medical, intellectual or psychological disability\n3. Contraindication for breastfeeding\n4. Children born with \\\u003C 2500 grams","12 Years",{"count":182,"type":21},1040,[104],"The goal of this clinical trial is to learn if a conditional social transfer works to improve rates of complementary breastfeeding. It will also learn about the impacts of social transfers on maternal and child health and development. The main questions it aims to answer are:\n\n* Does the social transfer increase complementary breastfeeding rates at 24-months postpartum?\n* Does the social transfer increase complementary breastfeeding duration?\n* Does the social transfer impact child health and development?\n* Does the social transfer impact maternal physical and mental health?\n\nResearchers will compare a conditional social transfer to a control group that only receives education about breastfeeding recommendations to see if a conditional social transfers works to increase complementary breastfeeding.\n\nParticipants will:\n\nReceive a pamphlet explaining the current recommendations of breastfeeding Receive instructions that if they meet the recommendation to breastfeed until 24-months postpartum they receive a social transfer or receive no additional information Complete home visits at 12- and 24-months postpartum Complete detailed questionnaire",[186,187,188,189,190,191,192,193,194,195,196,197,30,198,199,200,201],"Breastfeeding","Breastfeeding Education","Breastfeeding Duration","Breastfeeding Continuation","Child Growth","Stress","Infectious Diseases","Anemia","Child Development","Weight Loss","Blood Pressure","Mental Health","Coughing","Eczema","Allergies","Antibiotic Use",[203,204,205,206,207,208,209,210],"breastfeeding","cash transfer","child health","maternal health","mental health","child growth","child development","education","2026-04-28",{"date":140,"type":48},{"date":214,"type":21},"2026-06-01",{"date":216,"type":21},"2028-02-28",{"name":218,"class":55},"Swiss Tropical & Public Health Institute",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":17,"minAge":226,"maxAge":180,"enrollmentInfo":227,"targetDuration":4,"studyType":102,"phases":229,"briefSummary":231,"conditions":232,"keywords":235,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":256},"100614914","phase-4-rifaximin-200-mg-plus-oral-rehydration-vs-oral-rehydration-alone-in-children-with-acute-diarrhea-100614914","NCT07285785","Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea","A Randomized, Open-Label Study to Assess Pharmacokinetics of Xifaxan® 200 mg in Pediatric Subjects 6 to 11 Years of Age With Acute Diarrhea of Suspected Bacterial Etiology, and the Safety and Efficacy of Xifaxan® 200 mg Plus Oral Rehydration Therapy (ORT) Compared to ORT Alone","Inclusion Criteria:\n\n1. Consent and assent are appropriately obtained prior to any study related activities, including discontinuation of any prohibited medications (subjects must sign an assent for the study and a parent or a legal guardian must sign the informed consent).\n2. Subject is between 6 to 11 (and 11 months) years of age, inclusive, and weighs at least 15 kg (33 lbs) at Screening.\n3. Females of childbearing (reproductive) potential must have a negative urine and serum pregnancy test at Screening and agree to use a highly effective method of contraception throughout their participation in the study. Acceptable methods of contraception are those alone or in combination, that result in a low failure rate (ie, less than 1% per year) when used consistently and correctly and include hormonal methods (oral, injected or implanted), intrauterine device or intrauterine system or double barrier methods (simultaneous use of a physical barrier method by the subject and male partner, including a male condom and an occlusive cap \\[diaphragm or cervical\u002Fvault cap\\] with spermicidal). Abstinence or partner(s) with a vasectomy may be considered an acceptable method of contraception at the discretion of the Investigator.\n\n   NOTE: Female subjects are considered of child-bearing potential if they are (a) physiologically capable of becoming pregnant, defined as a female who has experienced menarche and (b) they will be, or could possibly be, engaging in sexual activity during the course of the study.\n4. Subject has diarrhea of suspected bacterial etiology defined by:\n\n   * At least 3 unformed stools in the last 24 hours prior to Screening.\n   * A fever ≥ 100.4°F (38°C) and ≤ 102.2°F (39°C) or has had a fever of ≥ 100.4°F (38°C) and ≤ 102.2°F (39°C) at any time since the development of abdominal pain or diarrhea.\n   * Illness for less than 96 hours at Screening.\n5. Parent or legal guardian and subject, when applicable based on aged, are capable of understanding the requirements of the study and willing to comply with all study procedures and visits.\n\nExclusion Criteria:\n\n1. Subject has a history of chronic diarrhea.\n2. Subject is unable to eat or drink.\n3. Subject has at least one of the following signs or symptoms:\n\n   * Presence of fever \\>39°C (\\>102.2°F).\n   * Presence of frank blood in stool.\n4. Subject has taken \\>2 doses of anti-diarrheal therapies in the 24 hours prior to randomization.\n5. Subject has taken any oral antimicrobial drug within 14 days of randomization.\n6. Subject has an unstable medical condition, in the opinion of the Investigator, (including, but not limited to, evidence of severe dehydration noted by tachycardia, abnormal blood pressure, or decreased skin turgor) at the Screening visit.\n7. Subject has known, clinically significant hepatic disease manifested by twice the age and sex-adjusted upper limit of normal (2 × ULN) for any of the following liver function tests: alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, alkaline phosphatase, or total bilirubin (except in isolated elevation of unconjugated bilirubin).\n8. Subject has known, clinically significant renal disease (eg, 1.5 × ULN of serum creatinine or 2 × ULN of blood urea nitrogen levels).\n9. Subject has serum sodium of ≥150 mEq\u002FL and serum potassium ≤3.0 mEq\u002FL.\n10. Subject has a known hypersensitivity or allergy to Xifaxan®, rifampin, rifamycin-derived antibiotics, or any of the components of the rifaximin (Xifaxan®) formulations used in this study.\n11. Subject is pregnant or lactating or plans to become pregnant during the study.\n12. Subject has had a previous history of malignancy.\n13. Subject has a history of tuberculosis infection and\u002For has received treatment for tuberculosis infection.\n14. Subject has any concurrent illness, disability or circumstance that may affect the interpretation of clinical data, could cause noncompliance with treatment or visits or otherwise contraindicates participation in this study in the opinion of the Investigator.\n15. Subject has had significant blood loss within the 30 days prior to the Screening visit which prevents the collection of the blood volume required for this study.\n16. Subject has participated in an investigational drug or device study within the 30 days prior to randomization.\n17. Subject's parent or legal guardian, or an immediate family member is an employee of the site that is directly involved in the management, administration, or support of this study.\n18. Subject and\u002For legal guardian is unwilling or unable to comply with the study protocol for any other reason.\n19. Subject has a serum glucose level at screening that deviates from the reference range established by the central laboratory.\n20. Subject is taking a concomitant medication that is a P-glycoprotein (P-gp) inhibitor.\n21. Subject is taking warfarin for a pre-existing condition.","6 Years",{"count":228,"type":21},54,[230],"PHASE4","The goal of this clinical trial is to learn how rifaximin 200 mg is processed in the body (pharmacokinetics) in children 6 to 11 years old with acute diarrhea that may be caused by bacteria. It will also learn about the safety and effectiveness of rifaximin when given with oral rehydration therapy (ORT) compared with ORT alone. The main questions it aims to answer are:\n\nHow does rifaximin 200 mg move through and leave the body in children with acute diarrhea?\n\nIs rifaximin safe for children in this age group?\n\nDoes rifaximin plus ORT help resolve diarrhea faster than ORT alone?\n\nResearchers will compare rifaximin plus ORT to ORT alone to see if adding rifaximin improves outcomes.\n\nParticipants will:\n\nTake one rifaximin 200 mg tablet + ORT three times a day for 3 days or receive ORT alone\n\nReceive oral rehydration therapy according to the investigator's standard of care\n\nAttend up to 4 clinic visits over 5 days and receive 4 follow-up phone calls\n\nProvide blood samples on Day 1 and Day 3 for pharmacokinetic testing (rifaximin group only)\n\nProvide stool samples to identify bacterial pathogens\n\nKeep a diary of stool frequency and consistency to help determine when diarrhea resolves\n\nBe monitored for side effects, vital signs, and laboratory changes",[30,233,234],"Gastroenteritis","Bacterial Infection",[236,237,238,239,240,241,242,243,244,245,246],"pediatric","children","rifaximin","xifaxan","Oral Rehydration Therapy (ORT)","acute diarrhea","bacterial diarrhea","gastroenteritis","open-label","randomized","ages 6-11","2026-03-17",{"date":249,"type":48},"2026-03-18",{"date":251,"type":48},"2026-02-11",{"date":253,"type":21},"2027-07-31",{"name":255,"class":145},"Bausch Health Americas, Inc.",5,{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":102,"phases":266,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":283,"locationsCount":56},"100365466","phase-1-fecal-microbiota-transplantation-in-treating-immune-checkpoint-inhibitor-induced-diarrhea-or-colitis-in-genitourinary-cancer-patients-100365466","NCT04038619","Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients","Fecal Microbiota Transplantation (FMT) for Immune-Checkpoint Inhibitor Induced-Diarrhea\u002FColitis in Genitourinary Cancer Patients","Inclusion Criteria:\n\n1. Diagnosis of any type of genitourinary (kidney, bladder and prostate), melanoma, non-melanoma skin cancer, lung, head \\& neck, sarcoma\u002Flymphoma, gastrointestinal system (luminal GI, hepatobiliary, pancreas), gynecology system (ovarian, uterine, cervical), and breast malignancies\n2. Treatment with any ICPI agent(s)\n3. Participants with new onset of ≥ grade 2 ICPI-induced diarrhea and\u002For colitis symptoms based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5 within 45 days prior to date of FMT treatment without involvement of non- GI toxicity\n4. Participants with a history of steroid use before FMT can be allowed if last dose was \\> 30 days prior to FMT treatment or treatment duration was for \\\u003C7 days beyond one week prior to FMT treatment\n5. Participants with a history of immunosuppressant (Infliximab, Vedolizumab etc) use before FMT can be allowed if last dose was administered ≥ 3 months prior to FMT treatment when used for the treatment of conditions other than for ICI- induced GI toxicities (e.g., Infliximab is used in the treatment of Crohn's disease, rheumatoid arthritis, plaque psoriasis, and Vedolizumab is used in treating ulcerative colitis)\n6. No concern for active concomitant GI infection at the time of initiation of protocol therapy as confirmed by stool tests or as per the treating physician based on clinical presentation\n7. Patient has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g., lifelong positive T-spot due to BCG inoculation, chronic colonization) prior to initiation of protocol therapy and\u002F or imaging (e.g. CXR, CT CAP etc) confirms the absence of active infections (e.g. TB) within 60 days prior to initiation of protocol therapy\n8. Ability to understand and willingness to sign an informed consent form\n9. Life expectancy \\> 6 months\n\nExclusion Criteria\n\n1. Age younger than 18 years\n2. Participants with persistent GI infection confirmed with positive stool test(s) despite completing 5 days of antibiotics prior to initiation of protocol therapy\n3. History of inflammatory bowel disease, and\u002For radiation enteritis or colitis with active disease status at the time of study treatment initiation\n4. Pregnant and breastfeeding women\n5. Women who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was \\> 1 year prior to consent and\u002F or clear documentation states that participant is peri- or post-menopausal or there has been recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to date of study treatment\n6. Immunosuppressive treatment at onset of ICPI-induced diarrhea\u002Fcolitis\n7. Any medical conditions (e.g. severe heart failure, brain hemorrhage, septic shock, etc.) that are high risk for colonoscopy procedure by the assessment of the study PI or Co-PIs.\n8. Participants who develop concurrent non-GI toxicity at the time of study treatment\n9. Donors at risk for monkeypox infection and\u002F or exposure as determined by a questionnaire",{"count":265,"type":21},40,[267],"PHASE1","This trial studies how well fecal microbiota transplantation works in treating diarrhea or colitis (inflammation of the intestines) that is caused by certain types of medications (called immune-checkpoint inhibitors) in patients with genitourinary cancer. Fecal microbiota transplantation may effectively reduce the incidence of immune checkpoint inhibitor-induced diarrhea\u002Fcolitis.",[270,30,271,272,273,274,275,276,277],"Colitis","Malignant Genitourinary System Neoplasm","Melanoma","Lung Cancer","Ovarian Cancer","Uterine Cancer","Breast Cancer","Cervical Cancer",{"date":279,"type":48},"2026-03-20",{"date":281,"type":48},"2021-02-01",{"date":116,"type":21},{"name":284,"class":55},"M.D. Anderson Cancer Center",{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":98,"sex":17,"minAge":292,"maxAge":293,"enrollmentInfo":294,"targetDuration":4,"studyType":102,"phases":296,"briefSummary":297,"conditions":298,"keywords":299,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":256},"100616042","phase-4-a-post-marketing-observational-study-of-oral-cholera-vaccine-100616042","NCT07300462","A Post-marketing Observational Study of Oral Cholera Vaccine","A Randomized, Double-blind, Placebo-Controlled Clinical Study to Evaluate the Protective Efficacy of Oral Recombinant Subunit B\u002FBacterial Cholera Vaccine (Enteric-coated Capsules) Against Infectious Diarrhea Caused by Non-Vibrio Cholerae in Healthy People Aged 2 to 14 Years","Inclusion Criteria:\n\n1. Age ≥ 2 years old, ≤ 14 years old, male or female.\n2. Not vaccinated against cholera.\n3. Obtain the consent of the study subject or guardian and sign the informed consent form.\n4. The subjects and their guardians were able to comply with the requirements of the clinical study protocol.\n5. Axillary temperature \\\u003C 37.0 °C was measured on the day of inoculation.\n\nExclusion Criteria:\n\n* Exclusion Criteria for First Inoculation：\n\n  1. Patients with febrile illness (axillary temperature ≥ 37.0 °C on the day of vaccination), other acute diseases, and diarrhea within 7 days before vaccination.\n  2. Use of antibiotics within 7 days prior to vaccination.\n  3. Patients with gastric ulcer, abnormal gastric acid secretion and other gastric diseases or discomfort.\n  4. History of allergy to vaccinations and oral medications.\n  5. Patients with congenital malformations, developmental disorders, or severe chronic diseases.\n  6. Suspected progressive neurological disorder, epilepsy, or long-term use of antibiotics.\n  7. Received blood products within 3 months prior to vaccination.\n  8. Received other investigational drugs within 30 days prior to vaccination.\n  9. Received any Rotavirus vaccine within 12 months prior to vaccination.\n  10. Live attenuated vaccine within 14 days or subunit or inactivated vaccine within 7 days prior to vaccination.\n  11. Asthma requiring urgent treatment, hospitalization, intubation, oral or intravenous corticosteroids for unstable past two years.\n  12. Patients with severe hypertension, heart, liver, kidney disease, and severe infectious diseases (acquired immunodeficiency syndrome and active tuberculosis).\n  13. Has a malignancy, is active or has been treated without definitive cure, or has the potential to relapse during the study.\n  14. Epilepsy, excluding epilepsy that has been discontinued within the past 3 years and has not recurred.\n  15. Patients with coagulation disorders.\n  16. Those who have had or are currently suffering from mental illness that have not been well controlled within the past two years due to psychological conditions that do not comply with protocol requirements, and who need to take drugs for psychosis.\n  17. In the judgment of the investigator, it is contrary to the protocol due to various medical, psychological, social or other conditions, or affects the subject to sign the informed consent.\n* Exclusion Criteria for Second and Third Oral Vaccines：\n\n  1. Those who have an allergic reaction at the time of the first or second vaccination.\n  2. Occurring in any of the first dose exclusion criteria after inclusion.\n  3. Serious adverse event causally related to first or second dose of study vaccine.","2 Years","14 Years",{"count":295,"type":21},6000,[230],"Chinese survey data indicate that the incidence rate of diarrhea in the general population ranges from 0.17 to 0.70 episodes per person-year, whereas among children under five years of age, the rate is significantly higher, ranging from 2.50 to 3.38 episodes per person-year. Over recent decades, rapid economic development has contributed substantially to the reduction of mortality associated with infectious diseases. However, emerging challenges-such as increasing antimicrobial resistance and heightened population mobility-have complicated efforts in infectious disease prevention and control. In a phase III clinical trial of the recombinant B subunit\u002Fbacterial whole-cell cholera vaccine (enteric-coated capsule), a statistically significant difference was observed in the overall incidence of diarrhea between the vaccinated group (12.9%) and the control group (26.7%) (P \\\u003C 0.01). Findings from similar vaccine studies conducted in Sweden have demonstrated cross-protection against diarrhea caused by enterotoxigenic Escherichia coli (ETEC) and other intestinal pathogens. Specifically, the vaccine conferred a 50% protection rate against Salmonella enterica infections, 82% against mixed infections involving ETEC and Salmonella, and 71% against mixed infections involving ETEC and other pathogens. Evidence from relevant studies suggests that the recombinant B subunit\u002Fbacterial whole-cell cholera vaccine may offer protective benefits against non-cholera infectious diarrhea. Nevertheless, there remains a paucity of real-world effectiveness data, particularly in pediatric populations who bear a disproportionately high burden of diarrheal disease.",[30],[300],"IV","2026-02-05",{"date":303,"type":48},"2026-02-09",{"date":305,"type":21},"2026-03",{"date":307,"type":21},"2027-06",{"name":309,"class":145},"Shanghai United Cell Biotechnology Co., Ltd",{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":318,"targetDuration":320,"studyType":23,"phases":4,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":56},"100622559","defining-ileorectal-syndrome-a-prospective-observational-study-100622559","NCT07385196","Defining Ileorectal Syndrome: a Prospective Observational Study","Trying to Define Ileorectal Syndrome: a Prospective Observational Study","DEFINE-IRS","Inclusion Criteria: Age ≥18 years\n\nHistory of ileorectal anastomosis or preserved rectum following colorectal surgery\n\nAbility to understand the study procedures and provide written informed consent\n\nWillingness to participate in prospective follow-up assessments -\n\nExclusion Criteria:\n\nAge \\\u003C18 years\n\nPermanent stoma\n\nTotal rectal excision\n\nInability to complete follow-up assessments\n\n\\-",{"count":319,"type":21},30,"10 Days","1. Study Title: Trying to Define Ilorectal Syndrome: A Prospective Observational Study\n2. Study Objective and Significance:\n\n   Primary Objective:\n\n   To prospectively evaluate the frequency, symptom severity, and impact on quality of life of ileorectal syndrome developing in patients who have undergone total colectomy and ileorectal anastomosis.\n\n   Secondary Objectives:\n   * To examine the relationship between postoperative bowel dysfunction and quality of life\n   * To investigate clinical factors affecting symptom severity This study aims to contribute to postoperative follow-up and management strategies by revealing patient-centered outcomes of ileorectal syndrome.\n3. Expected Benefits and Risks of the Study:\n\n   Expected Benefits\n   * Prospective and systematic evaluation of ileorectal syndrome\n   * Identification of factors affecting the quality of life of these patients\n   * Increased awareness in clinical follow-up Potential Risks\n   * The study is observational and questionnaire-based and does not involve additional medical risks\n   * No invasive procedures will be performed on the patients\n4. Type, scope, and design of the planned study:\n\n   * Type: Prospective, observational\n   * Scope: Single-center\n   * Design: Questionnaire-based clinical trial\n5. Number of patients and volunteers to be included in the study, their qualifications, and the rationale for selection:\n\n   * Total number of patients: 30\n   * Age range: ≥18 years\n   * Gender: Female and male This number was determined based on the appropriate patient population followed in our center.\n6. Parameters to be examined:\n\n   Demographic data (age, gender, BMI) Surgical indication Whether the surgery was performed openly or laparoscopically Level of anastomosis Maximum daily bowel movement frequency and duration Feeling of urgency Nocturnal bowel movements Fluid\u002Fgas incontinence - soiling Ileus in ADBG Whether electrolyte abnormalities developed Length of hospital stay Need for re-hospitalization Severity of symptoms based on patient reports and questionnaire questions\n7. Where and by whom the parameters will be examined\n\n   Data will be collected by the responsible investigator at the relevant clinic.\n8. Which parameters to be used in the study are routine for that disease group and which are specific to the study?\n\n   Routine: Demographic data, surgical information, laboratory results Study-Specific: Postoperative bowel functionality, symptom questionnaire\n9. Estimated study duration, start and end dates:\n\n   Start date: 1\u002F1\u002F2026 End date: 31\u002F12\u002F2026 Total duration: 12 months\n10. Inclusion, exclusion, and withdrawal criteria:\n\n    Inclusion Criteria\n    * Having undergone total colectomy and ileorectal anastomosis\n    * 18 years of age and older\n    * Providing written informed consent Exclusion Criteria\n    * Serious neurological disease affecting bowel function\n    * Patients with incomplete follow-up data Withdrawal\n    * At the patient's request\n    * If follow-up cannot be completed\n11. Termination criteria:\n\n    By the ethics committee Termination decision Unforeseen circumstances preventing the conduct of the study\n12. Statistical methods to be used in the evaluation of the data to be obtained as a result of the research:\n\n    * Descriptive statistics (mean, median, percentage)\n    * Parametric and non-parametric tests\n    * Analysis of the relationship between symptom severity and quality of life\n    * p \\\u003C 0.05 statistical significance level",[323,30,324,325],"Total Colectomy","Urgency Incontinence","Soilings, Fecal","2026-01-27",{"date":328,"type":48},"2026-02-03",{"date":330,"type":48},"2025-12-19",{"date":332,"type":21},"2027-02-15",{"name":334,"class":55},"Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital",{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":56},"100618978","the-auxiliary-effect-of-artificial-intelligence-in-the-detection-of-precancerous-lesions-in-proximal-colon-cancer-100618978","NCT07338643","The Auxiliary Effect of Artificial Intelligence in the Detection of Precancerous Lesions in Proximal Colon Cancer","The Auxiliary Effect of Artificial Intelligence in the Detection of Precancerous Lesions in Proximal Colon Cancer: A Multicenter Randomized Controlled Study","Inclusion Criteria:\n\n1.Patients with symptoms such as abdominal pain, black stools, constipation, or diarrhea undergo colonoscopy for diagnostic purposes.\n\nExclusion Criteria:\n\n1. Those with inflammatory bowel disease, colorectal cancer and surgical history, as well as those with familial polyposis syndrome\n2. Those with intestinal obstruction or malignant tumors\n3. Patients with colorectal lesions that need to be treated in stages.\n4. Other contraindications for colonoscopy examination.",{"count":343,"type":21},1200,"The investigators conducted a multicenter randomized controlled trial to explore the adjuvant effect of artificial intelligence in the detection of precancerous lesions in the proximal colon.This is a prospective, multicenter, single-blind, parallel randomized controlled trial.During the colonoscopy retraction process, the investigators aimed to compare the detection rates of proximal colon adenomas with and without the assistance of an AI(Artificial Intelligence) diagnostic device.",[346,347,29,30],"Abdominal Pain","Black Stools","2026-01-03",{"date":350,"type":48},"2026-01-14",{"date":352,"type":21},"2026-02-26",{"date":354,"type":21},"2028-08-01",{"name":356,"class":55},"Limian Er",{"id":358,"slug":359,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":155,"enrollmentInfo":363,"targetDuration":4,"studyType":102,"phases":365,"briefSummary":367,"conditions":368,"keywords":370,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":56},"100568687","early-phase-1-novel-pilot-study-to-treat-symptoms-of-ibs-with-diarrhea-using-combination-therapy-of-a-low-fodmap-diet-and-a-neuromodulator-100568687","NCT06684470","Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator","Inclusion Criteria:\n\n* Participants must meet all of the inclusion criteria to participate in this study:\n\n  * Adults (ages 18-70)\n  * Score of \\>175 on the IBS-SSS questionnaire\n  * Must meet Rome IV criteria for IBS-D\n  * If subject is of reproductive capability a negative urine pregnancy test must be available prior to entering the study\n  * Ability to understand study procedures and to comply with them for the entire length of the study\n\nExclusion Criteria:\n\n* All candidates meeting any of the below exclusion criteria at baseline will be excluded from study participation:\n\n  * Score of \\\u003C 175 on the IBS-SSS\n  * Prior diagnoses of: known celiac disease, small intestinal bacterial overgrowth, inflammatory bowel disease, or microscopic colitis\n  * Ongoing significant anxiety or depression\n  * A history of a known side effect to mirtazapine\n  * Prior treatment with a low FODMAP diet or mirtazapine without clinical benefit\n  * Active alcohol or drug abuse\n  * Inability to read or understand the consent form\n  * Any other medical or psychological reason that would prevent active participation in a research study\n  * Pregnant females",{"count":364,"type":21},20,[366],"EARLY_PHASE1","The purpose of this research is to study the added benefit of treating IBS symptoms with a medication called mirtazapine in treating IBS symptoms when paired with a low-FODMAP diet compared to a low-FODMAP diet alone. FODMAP stands for fermentable oligosaccharides, disaccharides, monosaccharides, and polyols. These are short-chain carbohydrates that can cause digestive distress in some people.\n\nYou have been asked to take part in this research because you have symptoms of diarrhea-predominant irritable bowel syndrome that may respond to treatment with a combination of a medication called mirtazapine and a low-FODMAP diet.",[369,30],"IBS - Irritable Bowel Syndrome",[30,371,135],"IBS","2025-12-10",{"date":374,"type":48},"2025-12-18",{"date":376,"type":48},"2024-12-19",{"date":378,"type":21},"2026-12-19",{"name":380,"class":55},"Mayo Clinic",{"id":382,"slug":383,"hasResults":11,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":4,"eligibilityCriteria":387,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":102,"phases":390,"briefSummary":391,"conditions":392,"keywords":394,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":406},"100577651","phase-1-a-study-of-ser-155-to-treat-diarrhea-in-people-on-immunotherapy-100577651","NCT06801067","A Study of SER-155 to Treat Diarrhea in People on Immunotherapy","A Single-Arm, Open-Label, Phase 1 Study to Assess Safety and Preliminary Efficacy of Cultivated Multi-Strain Live Bacterial Therapeutic SER-155 for First-Line Treatment of Immunotherapy-Related Enterocolitis","Inclusion Criteria:\n\n* Age \\> 18 years\n* Receipt of ICI (single-agent or combination) within the 180 days preceding screening.\n\nConcurrent treatment with cytotoxic chemotherapy or other tumor-directed agents is permitted.\n\n* Grade 2 - 3 diarrhea (i.e., increase of at least 4 bowel movements a day above baseline during the screening window), deemed by the treating provider as likely related to ICI therapy, with or without concomitant symptoms of grade 1 - 2 colitis (e.g.\n\nabdominal pain, bloody or mucoid stools)\n\n* Able to swallow oral medication\n* Individuals of childbearing potential willing to use a highly effective method of contraception (failure rate of \\\u003C1% per year when used consistently and correctly) for 30 days after the last dose of SER-155.\n* Willing to provide written informed consent, comply with the protocol, and understand the potential risks and benefits of study enrollment and treatment.\n\nExclusion Criteria:\n\n* Active GI infection, including untreated viral, bacterial or fungal cause(s) of diarrhea.\n* Received immunosuppressive therapies for suspected or confirmed irEC, including systemic corticosteroids (either oral or intravenous) and\u002For infliximab, vedolizumab or ustekinumab\n* Grade 3 colitis symptoms, i.e. severe abdominal pain or peritoneal signs\n* Admitted to the hospital for irEC\n* Prednisone (or steroid equivalent) dose \\> 10 mg a day for a non-GI irAE at time of screening\n* Pre-existing inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis) or microscopic colitis\n* Pregnant or lactating women\n* Any condition that requires ongoing prophylactic or therapeutic antibacterial antibiotics\n* Severe neutropenia, as defined by an absolute neutrophil count (ANC) \\\u003C 500 cells\u002Fmm\\^3, at time of screening\n* Treatment with investigational medications used for diarrhea\u002Fcolitis treatment and microbiome therapeutics within 30 days prior to enrollment\n* Known allergy or intolerance to oral vancomycin\n* Unable to comply with the protocol requirements\n* Any condition that in the opinion of the investigator may increase the risk of study participation and\u002For may interfere with the interpretation of study results",{"count":389,"type":21},15,[267],"The purpose of this study is to find out whether SER-155 may be a safe first treatment that causes few or mild side effects for people due to irEC.",[30,393],"Enterocolitis",[30,395,393,396,397],"SER-155","Memorial Sloan Kettering Cancer Center","24-231","2025-12-01",{"date":400,"type":48},"2025-12-02",{"date":402,"type":48},"2025-01-24",{"date":404,"type":21},"2027-01-24",{"name":396,"class":55},7,{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":411,"acronym":4,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":102,"phases":415,"briefSummary":416,"conditions":417,"keywords":419,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":426,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":119},"100516384","cholera-hospital-based-intervention-for-7-days-chobi7-water-sanitation-and-hygiene-wash-case-area-targeted-intervention-cati-100516384","NCT06003816","Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) Water, Sanitation, and Hygiene (WASH) Case Area Targeted Intervention (CATI)","Inclusion Criteria:\n\n* Index cholera patient have no running water inside of their home\n\nExclusion Criteria:\n\n* No one will be excluded because of age, sex, religion, or sexual preference",{"count":414,"type":21},3140,[104],"Objective: The investigators objective is to develop and evaluate the effectiveness of a case area targeted water, sanitation, and hygiene (WASH) intervention in reducing cholera infections and increasing sustained WASH behaviors in transmission hotspots in a ring around cholera cases.",[418,30],"Cholera",[420,421,422,423,424,425],"randomized controlled trial","water","sanitation","hygiene","case area targeted intervention","Bangladesh",{"date":400,"type":48},{"date":428,"type":48},"2023-10-18",{"date":430,"type":21},"2026-11-30",{"name":432,"class":55},"Johns Hopkins Bloomberg School of Public Health",{"id":434,"slug":435,"hasResults":11,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":128,"enrollmentInfo":440,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":442,"conditions":443,"keywords":445,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":56},"100613315","gut-microbiota-and-diarrhea-in-breast-cancer-patients-receiving-pyrotinib-100613315","NCT07264985","Gut Microbiota and Diarrhea in Breast Cancer Patients Receiving Pyrotinib","Gut Microbiota Changes in Breast Cancer Patients Treated With Pyrotinib and Correlation With Drug-Induced Diarrhea: An Observational Cohort Study","Inclusion Criteria:\n\n1. Patients aged 18-75 years, regardless of gender.\n2. Diagnosed with HER2-positive breast cancer and currently receiving pyrotinib treatment (either as monotherapy or in combination with endocrine therapy), with a treatment duration of ≥ 2 weeks.\n3. Voluntarily agree to participate in this study and provide written informed consent.\n\nExclusion Criteria:\n\n1. History of significant gastrointestinal diseases (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis, intestinal obstruction) or previous major gastrointestinal surgery.\n2. Recent use (within 1 month) of antibiotics, probiotics, or traditional Chinese medicine intended to alter intestinal function.\n3. Pregnant or lactating women.\n4. Patients who refuse to provide informed consent or explicitly express unwillingness to participate. Patients found not meeting the inclusion criteria after enrollment will be discontinued from the study.",{"count":441,"type":21},60,"Background:\n\nPyrotinib is an effective targeted drug for HER2-positive breast cancer, but it very frequently causes diarrhea, which can be severe enough to disrupt treatment and reduce patients' quality of life. The reason why some patients develop diarrhea while others do not is not well understood. Recent research suggests that the community of bacteria in the gut (gut microbiota) may play a key role in this side effect.\n\nWhat is the purpose of this study? This is an observational study (Phase 1) that aims to understand the relationship between pyrotinib treatment, changes in gut bacteria, and the occurrence of diarrhea. The main goal is to compare the gut bacteria of patients who develop diarrhea while taking pyrotinib with those who do not. Researchers hope to identify specific bacteria that might protect against diarrhea, which could lead to new ways to prevent or treat this side effect in the future.\n\nWhat will happen in the study? Patients with HER2-positive breast cancer who are being treated with pyrotinib will be invited to participate. They will be divided into two groups: those who experience diarrhea and those who do not. Participants will provide stool samples at specific time points (e.g., 2 and 4 weeks after starting pyrotinib). They will also allow researchers to collect information from their medical records about their clinical condition and diarrhea symptoms. No experimental intervention will be administered in this phase of the study; all patients will receive standard medical care.\n\nPotential Benefits:\n\nParticipants will not receive any direct benefit from this observational phase of the study. However, the information gathered may help scientists better understand pyrotinib-induced diarrhea and develop future strategies to help other breast cancer patients manage this side effect more effectively.",[276,444,30],"Drug-Related Side Effects",[446,30,447,448,449,450,451,452],"Pyrotinib","Gut Microbiota","HER2-Positive Breast Cancer","Microbiome","Drug Side Effect","Metagenomics","Observational Study","2025-11-24",{"date":455,"type":48},"2025-12-04",{"date":457,"type":21},"2025-12",{"date":459,"type":21},"2026-07",{"name":461,"class":55},"Hubei Cancer Hospital",{"id":463,"slug":464,"hasResults":11,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":98,"sex":17,"minAge":18,"maxAge":469,"enrollmentInfo":470,"targetDuration":4,"studyType":102,"phases":471,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":56},"100608774","phase-1-first-in-human-dose-escalation-study-evaluating-the-safety-and-immunogenicity-of-ivts-shigella-04-vaccine-in-healthy-young-adults-100608774","NCT07205926","First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults","First-in-human, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating the Safety and Immunogenicity of IVT Shigella-04 in Healthy Young Adults","Inclusion Criteria\n\nParticipants who meet all the following criteria may be included in the study:\n\n1. Age 18 to 49 years at the time of Dose 1\n2. Good general health status, as determined by medical history, physical examination, safety laboratory tests, ECG, vital signs, and clinical judgment\n3. BMI ≥ 18.0 kg\u002Fm2 and ≤ 32.0 kg\u002Fm2\n4. Negative alcohol breath test and urine drug screen results at Screening and on Day 1\n5. All women: negative serum pregnancy test at Screening and negative urine pregnancy on Day 1\n6. Women of childbearing potential (see definition in Section 6.6.1): willingness to use a highly effective form of contraception (see list in Section 6.6.1) through 28 days after the last IP dose\n7. Willingness to attend all protocol visits and to have all protocol-required procedures\n8. Provision of written informed consent\n\nExclusion Criteria\n\nParticipants who meet any of the following criteria will be excluded from the study:\n\n1. Currently lactating\n2. History of shigellosis or participation in a Shigella challenge study\n3. History of bloody diarrhea without alternative diagnosis\n4. History of inflammatory bowel disease\n5. History of anaphylaxis or angioedema\n6. History of malignancy, excluding nonmelanoma skin cancer, cervical carcinoma in situ, and malignancies considered cured \\> 5 years prior to Day 1\n7. History of diabetes mellitus (Individuals with diet-controlled diabetes or history of gestational diabetes are eligible if screening blood glucose is normal and there has been no requirement for antidiabetic medication in the last year.)\n8. Known hypersensitivity to any of the ingredients in IVT Shigella-04\n9. Inadequate venous access for repeated phlebotomy\n10. Any screening laboratory test result outside the normal range and grade ≥ 2 according to the FDA's toxicity grading scale for vaccine trials in healthy adults and adolescents; (Elevated creatine kinase and isolated elevations of bilirubin may be Grade 2 if hepatic transaminases are normal and the Investigator attributes the abnormality to exercise or Gilbert's syndrome. Potential cases of benign ethnic neutropenia should be discussed with the Medical Monitor)\n11. Positive serologic test for human HIV-1 or HIV-2 antibody, hepatitis B surface antigen, or hepatitis C antibody\n12. Immunodeficiency or chronic administration (\\> 14 consecutive days) of immunosuppressant or other immune-modifying drugs (see details in Section 6.6.2), including systemic glucocorticoids, within 6 months before Day 1 (topical, intra-articular, or inhaled glucocorticoids permitted)\n13. Previous receipt of a licensed or investigational Shigella vaccine\n14. Planned receipt of any other vaccine through Day 57\n15. Receipt of blood transfusion or blood product within 6 months before Day 1 or planned receipt through Day 57\n16. Receipt of any other IP within 90 days before Day 1 or planned receipt through the end of the study\n17. Planned elective hospitalization or surgical procedure through the end of the study\n18. Occupational exposure to Shigella (eg, laboratory work)\n19. Residence ≥ 6 months in a low-income or lower-middle-income country as defined by the World Bank (https:\u002F\u002Fdatatopics.worldbank.org\u002Fworld-development-indicators\u002Fthe-world-by-income-and-region.html)\n20. Employee of Inventprise, vendors, or research sites associated with the study\n21. Any medical, psychiatric, substance use, or social condition that, in the judgment of the Investigator, may pose a risk to the participant or interfere with protocol adherence, assessment of study objectives, or ability to provide informed consent\n\nTemporary Delay Criteria\n\nAdministration of IVT Shigella-04\u002Fplacebo will be delayed for any participant who meets any of the following criteria:\n\n1. Receipt of any vaccine in the past 7 days\n2. Febrile illness (eg, oral temperature ≥ 38.0°C), diarrhea, or other acute illness in the past 48 hours\n3. Presence of any other sign, symptom, or medication use that could inhibit the proper vaccine administration of IVT Shigella-04\u002Fplacebo or interpretation of diary data\n\nThese criteria are temporary or self-limiting, and IVT Shigella-04\u002Fplacebo may be administered once the time frame has elapsed\u002Fthe condition has resolved.","49 Years",{"count":441,"type":21},[267],"Phase 1 trial to evaluate the Safety and Immunogenicity of Inventprise's (IVT) Shigella-04 in Healthy Young Adults",[474,30],"Shigella","2025-11-17",{"date":477,"type":48},"2025-11-19",{"date":479,"type":48},"2025-10-09",{"date":481,"type":21},"2026-08-21",{"name":483,"class":145},"Inventprise Inc.",{"id":485,"slug":486,"hasResults":11,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":490,"eligibilityCriteria":491,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":492,"enrollmentInfo":493,"targetDuration":4,"studyType":102,"phases":495,"briefSummary":496,"conditions":497,"keywords":499,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":505,"leadSponsor":507,"locationsCount":119},"100611300","early-phase-1-use-of-a-complex-gut-bacterial-consortium-miti-001-for-the-treatment-of-irritable-bowel-syndrome-with-diarrhea-100611300","NCT07238790","Use of A Complex Gut Bacterial Consortium (MITI 001) for the Treatment of Irritable Bowel Syndrome With Diarrhea","A Phase 1 Study to Evaluate the Safety of a Complex Gut Bacterial Consortium (MITI 001) for the Treatment of Irritable Bowel Syndrome With Diarrhea","CURE-IBS-D","Inclusion Criteria:\n\n1. Age 18 to 65 years inclusive at the time of signing the informed consent.\n2. Diagnosis of IBS-D according to the Rome IV criteria (Lacy 2017).\n3. At least 1 of the following measures of microbiome dysfunction:\n\n   1. Primary bile acid proportion ≥ 12% in stool samples, or\n   2. Positive hydrogen breath test (with either glucose or lactulose substrate) (Rezaie 2017)\n4. Normal C-reactive protein level\n5. Gallbladder intact\n6. Willing to use appropriate contraception during the treatment period and for one week after the last study visit.\n\n   * Male participants with partners who are women of childbearing potential (WOCBP): Appropriate contraception includes condoms or other means considered adequate by the responsible Investigator.\n   * Female participants who are WOCBP: Appropriate contraception includes condoms, an intrauterine device, hormonal contraception, or other means considered adequate by the responsible Investigator.\n7. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.\n8. Able to tolerate the planned course of antibiotics, EGD, and colonoscopy with bowel lavage.\n\nExclusion Criteria:\n\n1. Inflammatory bowel disease\n2. Untreated enteric infections\n3. History of gastrointestinal (GI) surgery: All participants with GI surgeries below the pylorus will be excluded from this study. This includes participants with a history of colectomy, segmental colonic resection, and small bowel resections.\n4. Documented severe gastroparesis\n5. Active intestinal obstruction\n6. Dysphagia (oropharyngeal, esophageal, functional, or neuromuscular)\n7. History of recurrent aspiration episodes\n8. Any conditions associated with a high risk of bleeding, including but not limited to coagulopathy\u002Fbleeding disorder, severe liver disease, active or recent GI bleeding, or recent abdominal or other GI surgery\n9. Active diagnosis of major depressive disorder\n10. Severe immunodeficiency, inherited or acquired (e.g., human immunodeficiency virus, active chemotherapy or immunosuppressive medications \\[including steroids, biologic therapy, or bone marrow suppressive agent\\], or radiation therapy)\n11. Any other significant medical condition that could confound or interfere with evaluation of safety or tolerability or prevent compliance with the study protocol at the discretion of the Investigator\n12. Active antibiotic use (except protocol-specified antibiotics)\n13. Active treatment with high levels of immunosuppressive therapies (active chemotherapy or immunosuppressive medications \\[including steroids, biologic therapies, or bone marrow suppressive agents\\], or radiation therapy)\n14. Active anticoagulant or antiplatelet therapy, or use of other medications associated with a high risk of bleeding within 48 hours prior to endoscopy on Day 1\n15. Use of a probiotic within one month prior to dosing of MITI-001 on Day 1\n16. Simultaneous participation in another interventional clinical trial\n17. Renal insufficiency (estimated glomerular filtration rate \\\u003C 50 mL\u002Fmin)\n18. Absolute neutrophil count \\\u003C 1000 μL, platelet count \\\u003C 50 × 109\u002FL, or hemoglobin level \\\u003C 6.5 g\u002FdL\n19. Pregnant, breastfeeding, or planning pregnancy during the study period\n20. Active drug or alcohol use disorder\n21. Known allergy or anaphylaxis to vancomycin, metronidazole, ciprofloxacin, or polyethylene glycol\n22. Inability to comply with research requirements","65 Years",{"count":494,"type":21},13,[366],"While the pathophysiology of diarrhea-predominant irritable bowel syndrome (IBS-D) is complex and heterogeneous, dysbiosis of the gut microbiome is frequently observed, suggesting that a substantial subset of patients with irritable bowel syndrome (IBS) have symptoms that are initiated and\u002For perpetuated by a microbiome dysfunction. Successful randomized controlled trials (RCT) for IBS-D (Ford 2018; Black 2022) leveraging microbiome-targeted therapies (antibiotics or low microbiome fermentation diets) suggest the gut microbiome is at least partially involved in IBS symptoms. Furthermore, fecal microbiota transplantation (FMT) for patients with IBS-D has demonstrated promising results (El-Salhy 2020), supporting the possibility that altering the microbiome composition could ameliorate IBS-D symptoms.\n\nMITI-001 is a transplantable gut bacterial community composed of 157 live bacterial strains, encompassing 79 genera of commensal bacteria, that have been isolated from healthy donor stool, purified, and banked. The hypothesis of the proposed research is that MITI-001 can target the pathophysiologic lesion in a subset of IBS-D patients, restore the altered microbial metabolic process, and thus alleviate IBS-D symptoms.",[498,30],"IBS (Irritable Bowel Syndrome)",[500],"IBS with Diarrhea Predominance (IBS-D)","2025-11-16",{"date":503,"type":48},"2025-11-20",{"date":457,"type":21},{"date":506,"type":21},"2030-12",{"name":508,"class":55},"Stanford University",{"id":510,"slug":511,"hasResults":11,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":515,"eligibilityCriteria":516,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":517,"targetDuration":4,"studyType":102,"phases":518,"briefSummary":519,"conditions":520,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":56},"100531969","fmt-in-checkpoint-inhibitor-mediated-diarrhea-and-colitis-100531969","NCT06206707","FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis","Faecal Microbiota Transplantation for Immune Checkpoint Inhibitor-mediated Diarrhea\u002FColitis: a Randomised, Double-blind Pilot Efficacy and Safety Study","Immunobiome","Inclusion Criteria:\n\n1. Age 18 years or above.\n2. Histologically proven diagnosis of malignant melanoma and\u002For kidney cancer.\n3. Treatment with any immune checkpoint inhibitor (Nivolumab, Pembrolizumab, Cemiplimab, Atezolizumab, Durvalumab, Avelumab, Ipilimumab), alone or in combination, within the last 8 weeks.\n4. Grade 2 or higher CTCAE diarrhea, of which at least 3 stools are Bristol chart score 6-7.\n5. Negative PCR for enteric pathogens including C. difficile, after the onset of diarrhea.\n6. Signed written informed consent.\n\nExclusion Criteria:\n\n1. Diagnosed bacterial infection requiring antibiotic treatment at inclusion.\n2. Pregnancy or breastfeeding. Pregnancy ruled out by male sex, postmenopausal women or a negative choriogonadotropin (hCG) urine test.\n3. Primary diarrheal disease pre-existing to the immune checkpoint inhibitor treatment, including inflammatory bowel disease.\n4. Unable to ingest capsules.\n5. Unable to understand written or oral patient information.",{"count":364,"type":21},[104],"The goal of this clinical trial is to determine the outcome of patients with immune checkpoint inhibitor-mediated diarrhea\u002Fcolitis (IMC) treated with faecal microbiota transplantation (FMT) in a randomised, placebo-controlled trial.\n\nThe aim of the present study is to assess the feasibility, pilot efficacy, and safety of FMT for patients with IMC.\n\nParticipants will be treated two times with capsule FMT or placebo capsules in a 1:1 ratio. The intervention treatment will be an add-on to the patients' standard treatment for IMC.\n\nResearchers will compare the FMT-treated group to the placebo-treated group to see if FMT promotes remission of IMC.",[30,270,521,522],"Malignant Melanoma","Kidney Cancer","2025-11-14",{"date":475,"type":48},{"date":526,"type":48},"2024-01-23",{"date":528,"type":21},"2026-10-31",{"name":530,"class":55},"University of Aarhus",{"id":532,"slug":533,"hasResults":11,"nctId":534,"briefTitle":535,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":98,"sex":17,"minAge":64,"maxAge":537,"enrollmentInfo":538,"targetDuration":4,"studyType":102,"phases":540,"briefSummary":542,"conditions":543,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":555},"100479151","phase-3-lactoferrin-and-lysozyme-supplementation-for-long-term-diarrhea-sequelae-100479151","NCT05519254","Lactoferrin and Lysozyme Supplementation for Long-term Diarrhea Sequelae","Inclusion Criteria:\n\n* Age 6-24 months\n* Managed as an outpatient or inpatient for diarrhea at one of the recruiting sites\n* MUAC \\\u003C12.5 cm at the time of screening\n* Plan to stay within the study area for the next 6 months or greater\n\nExclusion Criteria:\n\n* Age younger than 6 months or older than 24 months\n* Caregiver does not provide consent to study participation\n* History of 2 or more blood transfusions in the past 12 months\n* Exclusively breastfeeding at the time of enrollment\n* History of congenital defect or syndrome that prevents age-appropriate feeding (e.g. cleft palate)\n* History of allergy to dairy products\n* Child is not ready to return home (is not yet discharged), or discharged against medical advice\n* Unwilling to participate in the dual sugar permeability sub-study if selected\n* Enrollment in another study","24 Months",{"count":539,"type":21},600,[541],"PHASE3","Children in low- and middle-income countries who are hospitalized for diarrhea and also have malnutrition are at high risk for illness and death in the 6 months period following treatment for diarrhoea despite receiving current guideline recommended diarrhea management (such as oral rehydration solution, or \"ORS\"). This study will test whether nutritional supplements made from milk (lactoferrin or lysozyme) or a combination of the two (lactoferrin and lysozyme) will prevent children from having repeated diarrhea episodes and help improve their nutrition by improving their stomach health or preventing new disease during this 6-month period. The study is taking place at 7 hospitals in Western Kenya. Six hundred participants will be enrolled if they provide informed consent to participate, are aged 6-24 months, were hospitalized with diarrhea and malnutrition and have been managed by the facility nutritionists and ready to return home. Participation in the study will entail providing information on the child's health history, collection of stool samples, blood, and potentially urine. The caregiver will be provided sachets of the investigational product to take home and mix daily with their child's porridge or other complimentary food, and asked to return to the clinic 4 times in the subsequent 6 months, and also consent to having a community health worker visit their home every two weeks for a follow up visit. The risks to the participant and their caregiver are minimal. The information gained in this study will help us create new treatments and develop new strategies to treat sick children to prevent death and illness.",[30,544,545],"Wasting","Malnutrition, Child","2025-09-04",{"date":548,"type":48},"2025-09-11",{"date":550,"type":48},"2023-03-10",{"date":552,"type":21},"2026-12",{"name":554,"class":55},"University of Washington",4,{"id":557,"slug":558,"hasResults":11,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":562,"eligibilityCriteria":563,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":564,"targetDuration":4,"studyType":102,"phases":565,"briefSummary":566,"conditions":567,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":56},"100490257","phase-2-prophylactic-mesalamine-to-prevent-colitis-following-treatment-with-ipilimumabnivolumab-ipinivo-100490257","NCT05663775","Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab\u002FNivolumab (Ipi\u002FNivo)","Prophylactic Oral Mesalamine for the Prevention of Immune-Related Colitis in Patients Treated With Ipilimumab\u002FNivolumab","IMPACT 1","Inclusion Criteria:\n\n1. Patients must be 18 years of age or older.\n2. Patients with histologically confirmed, unresectable stage III or IV malignant melanoma.\n3. Patients must be capable of providing consent to enrolment and treatment.\n4. Patients with a performance status of ECOG 0-224 will be eligible for enrolment (see appendix16.1).\n5. Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level \\> 40 mIU\u002FmL to confirm menopause.\n6. Patients of childbearing \u002F reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period and for a period of 30 days after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.\n\n   -Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.\n7. Female patients who are breast-feeding should discontinue nursing prior to the first dose of study treatment and until 30 days after the last dose of study drug.\n8. Male patients should agree to not donate sperm during the study and for a period of at least 30 days after last dose of study drug\n9. Absence of any condition hampering compliance with the study protocol and follow- up schedule; those conditions should be discussed with the patient before registration in the trial.\n\n   * The following adequate organ function laboratory values must be met:\n\nHematological:\n\n* Absolute neutrophil count (ANC) \\>1.5 x109\u002FL\n* Platelet count \\>100 x109\u002FL\n* Hemoglobin \\>9 g\u002FdL (may have been transfused)\n\nRenal:\n\no Estimated creatinine clearance ≥ 30 mL\u002Fmin according to the Cockcroft-Gault formula (or local institutional standard method)\n\nHepatic:\n\n* Total serum bilirubin \\\u003C2x ULN\n* AST and ALT \\\u003C2.5x ULN (or ≤ 5 x ULN for subjects with documented metastatic disease to the liver)\n\nExclusion Criteria:\n\n1. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to enrollment), myocardial infarction (\\\u003C 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.\n2. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n3. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (CTCAE v5 Grade ≥ 3).\n4. Other severe acute or chronic medical conditions or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.",{"count":364,"type":21},[132],"The study team's principal interest is to address the question, \"Will prophylactic treatment with mesalamine reduce the incidence and severity of immune-related diarrhea occurring secondarily to treatment with ipi\u002Fnivo?\"",[568,30,569,570],"Immune-related Adverse Event","Advanced Melanoma","Advanced Rectal Carcinoma","2025-06-24",{"date":573,"type":48},"2025-06-27",{"date":575,"type":48},"2024-08-20",{"date":577,"type":21},"2027-08",{"name":579,"class":55},"AHS Cancer Control Alberta",{"id":581,"slug":582,"hasResults":11,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":11,"sex":17,"minAge":588,"maxAge":589,"enrollmentInfo":590,"targetDuration":4,"studyType":102,"phases":591,"briefSummary":592,"conditions":593,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":603,"locationsCount":4},"100592218","phase-4-impact-of-probiotics-on-antibiotic-associated-diarrhea-in-community-acquired-pneumonia-100592218","NCT06990568","Impact of Probiotics on Antibiotic-associated Diarrhea in Community-acquired Pneumonia","The Effect of Probiotic Administration on the Incidence of Antibiotic-associated Diarrhea in Patients With Community-acquired Pneumonia","PROBIO","Inclusion Criteria:\n\n* Adult patients aged 19 years or older admitted with a diagnosis of community-acquired pneumonia\n* Patients eligible for oral medication administration (able to take oral or enteral feeding)\n\nExclusion Criteria:\n\n* Sepsis patients\n* Patients admitted to the intensive care unit (ICU) following endotracheal intubation\n* Elderly patients aged 80 years or older\n* Pregnant women\n* Patients who have diarrhea at the time of admission\n* Patients with a history of using probiotics within 3 months prior to admission\n* Patients with a history of using laxatives within 1 week prior to admission\n* Patients suspected of being in shock (mean arterial pressure \\\u003C 65 mmHg) at the time of admission","19 Years","79 Years",{"count":20,"type":21},[230],"The study goal is to determine whether oral administration of a probiotic mixture can reduce the incidence of antibiotic-associated diarrhea in patients with community-acquired pneumonia.",[594,595,30],"Pneumonia","Probiotics","2025-05-23",{"date":598,"type":48},"2025-05-25",{"date":600,"type":21},"2025-06-01",{"date":602,"type":21},"2026-12-31",{"name":604,"class":55},"National Health Insurance Service Ilsan Hospital",{"id":606,"slug":607,"hasResults":11,"nctId":608,"briefTitle":609,"officialTitle":609,"acronym":610,"eligibilityCriteria":611,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":102,"phases":614,"briefSummary":615,"conditions":616,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":56},"100589877","clinical-study-on-fecal-microbiota-transplantation-for-diarrhea-after-total-pancreatectomy-100589877","NCT06960122","Clinical Study on Fecal Microbiota Transplantation for Diarrhea After Total Pancreatectomy","FMT-TP","Inclusion Criteria:\n\n1. Age ≥18 years, regardless of gender.\n2. Anticipated survival ≥3 months.\n3. Severe post-total pancreatectomy diarrhea (as per HART score).\n4. Willing and able to provide written informed consent and complete follow-up assessments.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 1-3.\n6. No use of oral\u002Fintravenous broad-spectrum antibiotics within 3 days prior to enrollment.\n7. Ability to swallow capsules intact without chewing.\n8. Adequate organ function confirmed by screening-phase laboratory tests.\n\nExclusion Criteria:\n\n1. Major organ insufficiency\u002Ffailure, including but not limited to:\n\n   Cardiac insufficiency or heart failure Renal insufficiency or renal failure Hepatic insufficiency or liver failure\n2. Uncontrolled or severe infections.\n3. Documented history of:\n\n   Psychoactive drug abuse Alcoholism Illicit drug use\n4. Severe infections complicated by sepsis or septicemia.\n5. History of severe allergic reactions or known hypersensitivity to components of liquid live-bacterial enteric-coated capsules.\n6. Pregnancy or lactation, or women of childbearing potential refusing contraceptive measures during the 15-week observation period.\n7. Gastrointestinal perforation and\u002For fistulas.\n8. Other conditions deemed ineligible by the investigator.",{"count":613,"type":21},10,[104],"By 2030, pancreatic cancer is projected to become the second leading cause of cancer-related deaths, with a 5-year survival rate below 10%. Approximately 20% of patients are diagnosed at a borderline resectable or resectable stage, and surgical resection remains the only curative option. However, total pancreatectomy (TP) often leads to severe diarrhea (incidence rate: 43.5%) due to exocrine insufficiency, and current pancreatic enzyme replacement therapy shows limited efficacy in some patients.\n\nRecent studies highlight the critical role of gut microbiota in pancreatic cancer progression and postoperative recovery. Patients with pancreatic ductal adenocarcinoma (PDAC) exhibit a 1000-fold increase in intrapancreatic bacterial load compared to normal tissues, with significantly elevated Bacteroides abundance and reduced Firmicutes and Proteobacteria in fecal samples. Postoperative dysbiosis is linked to complications; for example, diarrhea after cholecystectomy is dominated by Proteobacteria, suggesting that microbial imbalance may underlie diarrhea following TP.\n\nTo address this, the study proposes fecal microbiota transplantation (FMT) via oral capsules. FMT has proven effective in treating recurrent Clostridium difficile infection by restoring healthy microbiota. This research will systematically evaluate the efficacy and safety of FMT in alleviating post-TP diarrhea through clinical indicators and 16S rDNA sequencing, offering novel insights into postoperative management of pancreatic cancer.",[617,30],"Pancreatic Cancer, Resected","2025-04-28",{"date":620,"type":48},"2025-05-07",{"date":622,"type":21},"2025-05-01",{"date":624,"type":21},"2028-12-31",{"name":626,"class":55},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":628,"slug":629,"hasResults":11,"nctId":630,"briefTitle":631,"officialTitle":632,"acronym":633,"eligibilityCriteria":634,"healthyVolunteers":11,"sex":17,"minAge":22,"maxAge":537,"enrollmentInfo":635,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":637,"conditions":638,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":56},"100518475","prevalence-and-natural-history-of-functional-gastrointestinal-disorders-among-at-risk-infants-100518475","NCT06031025","Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.","Prospective Assessment of the Prevalence and Natural History of Gastroesophageal Reflux and Functional Gastro-intestinal Disorders Among At-risk Infants","FUSID","Inclusion Criteria:\n\n* infants with gestational age at birth \\\u003C 31 weeks\n* infants with gestational age at birth \\\u003C 37 weeks and major respiratory or neurologic morbidity\n* infants with history of perinatal asphyxia\n\nExclusion Criteria:\n\n* lack of informed consent\n* diagnosis of congenital or other major gastrointestinal disease (i.e. inflammatory bowel disease, cancer)",{"count":636,"type":21},71,"The goal of this observational study is to learn about the prevalence and characteristics of functional gastrointestinal disorders (FGID) in at risk infants (former preterm infants and those with birth asphyxia) during the first 2 years of life. The main questions it aims to answer are:\n\n* evaluate the prevalence of symptoms related to gastro-esophageal reflux (GER), of functional gastrointestinal disorders during the first 2 years of life\n* describe growth parameters during follow-up up to the corrected age of 2 years Participants will be assessed clinically and with a structured questionnaire based on the Rome IV criteria to describe FGID.",[639,640,641,30,642,643,644],"Functional Gastrointestinal Disorders","Gastroesophageal Reflux","Constipation - Functional","Dyschezia","Colic, Infantile","Vomiting; Cyclical","2025-03-10",{"date":647,"type":48},"2025-03-11",{"date":649,"type":48},"2022-05-20",{"date":651,"type":21},"2025-09-30",{"name":653,"class":55},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":655,"slug":656,"hasResults":11,"nctId":657,"briefTitle":658,"officialTitle":659,"acronym":4,"eligibilityCriteria":660,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":155,"enrollmentInfo":661,"targetDuration":4,"studyType":102,"phases":662,"briefSummary":663,"conditions":664,"keywords":665,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":672,"lastUpdatePostDateStruct":673,"startDateStruct":675,"completionDateStruct":676,"leadSponsor":678,"locationsCount":56},"100580615","phase-1-cmts4520-assisted-washed-microbiota-transplantation-for-chronic-diarrhoea-in-adults-100580615","NCT06839599","CMTS4520-Assisted Washed Microbiota Transplantation for Chronic Diarrhoea in Adults","The Efficacy and Safety of CMTS4520-Assisted Washed Microbiota Transplantation for Chronic Diarrhoea in Adults： a Randomized, Double-Blind, Placebo-Controlled Trial.","Inclusion Criteria:\n\nMeet all of the following inclusion criteria :\n\n1. Voluntary sign informed consent, age 18-70 years old (including the threshold), male and female.\n2. Using the Rome IV criteria as the diagnostic criteria:\n\n   1. Defecation frequency is greater than or equal to 3 times per day or significantly exceeds the usual habit, with a disease duration of \\> 4 weeks, or recurrent diarrhea with an intermittent period within 2 - 4 weeks;\n   2. Loose stools: Types 5, 6, and 7 based on the Bristol Stool Form Scale.\n3. The subject or his\u002Fher legal representative has given informed consent, is fully aware of the purpose of the study, is able to communicate well with the investigator, and is able to understand and comply with the requirements of the study.\n\nExclusion Criteria:\n\nAll exclusion criteria below are not met:\n\n1. Participants with a history of intestinal resection.\n2. Participants with organic lesions of the digestive tract (e.g., tumor, inflammation, anal fissures, Crohn's disease, ulcerative colitis, radiation enteritis, intestinal adhesions, intestinal tuberculosis) as confirmed by colonoscopy within the past 24 months.\n3. Participants with diarrhoea secondary to systemic diseases affecting the digestive tract, including:\n\n   1. Neurological diseases (e.g., Parkinson's disease, spinal cord injury, multiple sclerosis).\n   2. Muscle diseases (e.g., amyloidosis, dermatomyositis).\n   3. Psychiatric disorders or severe mood disorders (e.g., A Hospital Anxiety and Depression Scale score ≥15).\n   4. Opioid-induced diarrhoea.\n   5. Poorly controlled metabolic diseases (e.g., thyroid dysfunction) or metabolic diseases with gastrointestinal complications (e.g., gastrointestinal autonomic dysfunction, diabetic gastroparesis).\n4. Diarrhea secondary to intestinal infectious diseases, including but not limited to Clostridioides difficile infection, chronic bacillary dysentery, intestinal tuberculosis, and parasitic infection-induced diarrhea.\n5. Have a history of major surgery or severe trauma within 3 months and have not fully recovered.\n6. Participants with any of the following cardiac abnormalities:\n\n   1. New York Heart Association (NYHA) Class III or higher heart failure.\n   2. Myocardial infarction or unstable angina within the past 6 months.\n   3. Prolonged QTc interval on electrocardiogram (≥450ms for males, ≥470ms for females).\n   4. Atrial arrhythmias that cannot be stably controlled by drugs and ventricular arrhythmias requiring pharmacological control (including grade 2 or higher atrioventricular block).\n7. Participants with poor lung function, as assessed by the investigator, that may impact study treatment, such as acute chronic obstructive pulmonary disease(COPD) or those requring long-term oral, intravenous corticosteroids (excluding inhalant\u002Fspray formulations).\n8. Uncontrolled immune diseases requring long-term systemic corticosteroid use (excluding topical use).\n9. Participants with reproductive system disorders that may cause abdominal pain (e.g., ovarian cysts, endometriosis, primary dysmenorrhea).\n10. Participants with significant laboratory abnormalities that, in the investigator's judgment, may affect safety or study completion, including:\n\n    1. Hemoglobin \\\u003C100g\u002FL.\n    2. Serum creatinine ≥1.5 times the upper limit of normal (ULN).\n    3. Abnormal liver function (AST\\>1.5×ULN, ALT\\>1.5×ULN or total bilirubin \\>1.5×ULN).\n    4. Clinically significant abnormalitieshe in routine stool tests or fecal occult blood indicating gastrointestinal lesions.\n11. Participants with active hepatitis (requiring or undergoing long-term treatment), HIV, or active tuberculosis.\n12. Participants with a history of drug or alcohol abuse (defined as consuming more than 14 standard drinks peer week: 1 standard drink= 360mL of beer, 45mL of 40% spirits, or 150mL of wine) or substance abuse.\n13. Participants with known allergies or intolerances to the investigational drug, similar drugs or excipients.\n14. Participants who have used anti-infective drugs (antibiotics, antifungals, antivirals) within 14 days prior to enrollment or require anti-infective treatment at the time of enrollment evaluation.\n15. Participants who have used drugs or foods that regulate gut microbiota (e.g., bifidobacterium, probiotics, prebiotics, fermented milk, yogurt) within 2 weeks prior to screening or during the study.\n16. Women who are pregnant, breastfeeding, or unwilling to use effective contraception for 3 months after the last dose of the study drug.\n17. Participants who have participated in drug intervention clinical trials within 1 month prior to enrollment.\n18. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.",{"count":20,"type":21},[267,132],"This is a randomized controlled trial to explore the efficacy and safety of CMTS4520 (Dietary Fiber Probiotics) assisted washed microbiota transplantation for patients with chronic diarhoea.",[30],[666,667,668,669,670,671],"washed microbiota transplantation","diarrhea","CMTS4520","randomized controlled study","dietary fiber","probiotics","2025-02-20",{"date":674,"type":48},"2025-02-21",{"date":672,"type":21},{"date":677,"type":21},"2030-07-01",{"name":679,"class":55},"The Second Hospital of Nanjing Medical University",{"id":681,"slug":682,"hasResults":11,"nctId":683,"briefTitle":684,"officialTitle":685,"acronym":686,"eligibilityCriteria":687,"healthyVolunteers":98,"sex":154,"minAge":4,"maxAge":4,"enrollmentInfo":688,"targetDuration":4,"studyType":102,"phases":690,"briefSummary":691,"conditions":692,"keywords":698,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":707,"startDateStruct":709,"completionDateStruct":711,"leadSponsor":713,"locationsCount":119},"100498174","coupons-for-safe-water-project-100498174","NCT05766826","Coupons for Safe Water Project","Scaling up Coupons for Safe Water Treatment in Kenya","Coupons","Inclusion Criteria:\n\n* Currently pregnant women\n* Women living inside Health and Demographic Surveillance Systems (HDSS) catchment areas.\n\nExclusion Criteria:\n\n\\- Women who do not consent.",{"count":689,"type":21},3468,[104],"Guaranteeing access to safe drinking water is still a challenge in rural households in developing countries, and unsafe water sources are responsible for millions of deaths each year around the world. Coupons for free dilute chlorine solution are a cost-effective and effective way of ameliorating child health and reducing diarrhea incidence. It is still an empirical challenge, however, to see if the positive health effects will be maintained when the program is implemented at scale. In this study, investigators conduct a randomized controlled trial (RCT) at scale to study the impacts of a chlorine coupon program implemented at health clinics on child health, including self-reported diarrhea, fever, and cough incidence in the previous two weeks. Investigators further investigate the pathway of the impact, such as self-reported and objectively measured use of chlorine and frequency of visits to health clinics.",[693,694,30,695,696,697],"Death","Death, Infant","Diarrhea, Infantile","Water-Borne Infectious Disease","Water-Related Diseases",[699,700,701,702,703,686,704,705,706],"Child health","Child mortality","Chlorine","Safe water","Targeting","RCT","East Africa","Kenya",{"date":708,"type":48},"2023-03-13",{"date":710,"type":48},"2023-02-21",{"date":712,"type":21},"2026-10-01",{"name":714,"class":55},"University of Chicago"]