[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shenzhen Hospital of Southern Medical University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":124},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,39,68,98],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100616723","inactivated-bacteroides-fragilis-for-prevention-of-chemotherapy-induced-diarrhea-100616723",false,"NCT07309315","Inactivated Bacteroides Fragilis for Prevention of Chemotherapy-Induced Diarrhea","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form, be able to comply with the protocol and have the capacity to complete relevant procedures.\n2. Aged ≥ 18 years old (based on the date of signing the ICF), regardless of gender.\n3. Patients with malignant tumors confirmed by pathology or cytology.\n4. Patients scheduled to receive the following initial treatments at the standard dose specified in the protocol:\n\n   * Cohort 1: Patients with advanced colorectal cancer receiving the FOLFIRI regimen (irinotecan + fluorouracil + leucovorin);\n   * Cohort 2: Patients with breast cancer receiving neratinib treatment.\n5. ECOG performance status score of 0-1 at the start of the study.\n6. Expected survival time ≥ 12 weeks.\n7. Subjects of childbearing potential (including males and females) agree to adopt effective contraceptive measures approved by the investigators (e.g., intrauterine device, contraceptive pills or condoms) during the trial and within 3 months after the trial ends. Female subjects of childbearing potential must have a negative result in serum human chorionic gonadotropin (hCG) test.\n\nExclusion Criteria:\n\n1. History of altered bowel habits or abnormal stool characteristics prior to screening that, in the investigator's opinion, would preclude subsequent efficacy evaluation; or use of laxatives within 7 days prior to randomization; or use of antidiarrheal agents within 48 hours prior to randomization.\n2. Complicated with diseases causing diarrhea, including but not limited to inflammatory bowel disease (e.g., ulcerative colitis and Crohn's disease), suspected or confirmed infectious diarrhea, irritable bowel syndrome, celiac disease, etc.\n3. Receipt of any chemotherapeutic agents or PD-1 antibodies other than the chemotherapy\u002Ftreatment regimen specified in the protocol during the trial.\n4. Concurrent abdominopelvic radiotherapy during the trial period; or unresolved radiotherapy-induced enteritis caused by previous abdominopelvic radiotherapy.\n5. Medical history of chronic use of laxatives (≥ 30 non-consecutive days).\n6. Need for antibiotic treatment during the trial or long-term use of antibiotics prior to randomization.\n7. Patients with stomas, including temporary stomas that have not been closed or patients whose bowel function has not recovered after stoma closure.\n8. Presence of unhealed surgical wounds, ulcers or fractures.\n9. Known history of human immunodeficiency virus (HIV) infection (positive HIV antibody test).\n10. History of allergy or suspected allergy to antidiarrheal drugs (e.g., loperamide and its components).\n11. Suspected or confirmed history of alcohol or drug abuse.\n12. Pregnant or lactating women.\n13. Concurrent participation in other clinical trials.\n14. Other conditions deemed inappropriate for study participation by the investigator.","ALL","18 Years",{"count":18,"type":19},200,"ESTIMATED","INTERVENTIONAL",[22],"NA","The incidence of chemotherapy-induced diarrhea (CID) is closely related to the types of anticancer drugs. Combination chemotherapy regimens such as fluorouracil derivatives and irinotecan, as well as tyrosine kinase inhibitors like neratinib, are associated with a high severity and incidence of diarrhea. These All antineoplastic agents can induce intestinal epithelial cell apoptosis, damage the intestinal mucosa, subsequently reduce the absorption surface area, and thereby lead to diarrhea. Recent literature has indicated that Bacteroides fragilis may be a candidate drug for the treatment and prevention of CID. This study intends to conduct a randomized controlled trial to determine the efficacy and mechanism of action of inactivated Bacteroides fragilis (SK10) in the prevention of chemotherapy-induced diarrhea (CID).",[25],"Chemotherapy-induced Diarrhea","RECRUITING","2026-06-03",{"date":29,"type":30},"2026-06-05","ACTUAL",{"date":32,"type":30},"2026-03-13",{"date":34,"type":19},"2026-12-30",{"name":36,"class":37},"Shenzhen Hospital of Southern Medical University","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":45,"sex":46,"minAge":16,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":67,"locationsCount":4},"100593212","explore-the-risk-factors-for-antenatal-mental-disorders-in-pregnant-women-with-hyperglycemia-100593212","NCT07003503","Explore the Risk Factors for Antenatal Mental Disorders in Pregnant Women With Hyperglycemia","Inclusion Criteria:\n\n* The pregnant woman was confirmed to have gestational diabetes through biochemical tests and glucose tolerance tests, etc.\n* Possess the abilities of listening, speaking, reading, writing and comprehension, and be capable of effective communication;\n* Age: 18-45 years old (including 18 and 45 years old);\n* informed consent and voluntary participation in the research;\n* Gestational age: 28 to 37 weeks (including 28 weeks but excluding 37 weeks).\n\nExclusion Criteria:\n\n* Abnormal fetuses, multiple pregnancies;\n* Other pregnancy complications and comorbidities, such as heart disease, preeclampsia, liver disease, etc.\n* There is a history of mental illness or mental disorders in the past.\n* Those who are unable to communicate effectively by using listening, speaking, reading and writing skills;\n* Patients with diabetes mellitus complicated with pregnancy;\n* Those who use psychotropic or neurotropic drugs.",true,"FEMALE","45 Years",{"count":49,"type":19},635,"OBSERVATIONAL","This study aims to investigate the current situation and risk factors of adverse mental disorders in pregnant women with hyperglycemia. it could include any of the following: 18-45 years old pregnant women with hyperglycemia. The main question is to answer the risk factor for antenatal mental disorder. participants need to complete a self-report questionnaire.",[53,54,55],"Hyperglycemia","Mental Disorder","Pregnancy Complications",[57,58,59],"hyperglycemia","antenatal mental disorder","pregnancy complication","NOT_YET_RECRUITING","2025-05-26",{"date":63,"type":30},"2025-06-04",{"date":65,"type":19},"2025-06-30",{"date":34,"type":19},{"name":36,"class":37},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":20,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":38},"100538944","phase-2-efficacy-and-safety-of-fmt-for-the-treatment-of-ibs-d-and-mental-health-comorbidity-in-young-adults-100538944","NCT06297421","Efficacy and Safety of FMT for the Treatment of IBS-D and Mental Health Comorbidity in Young Adults","Efficacy and Safety of Fecal Microbiota Transplantation for the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) and Mental Health Comorbidity in Young Adults: A Randomized, Double-blind, Placebo Controlled Study","Inclusion Criteria:\n\n1. Voluntarily sign informed consent, be able to comply with the protocol and be able to carry out related procedures, including the completion of diary during the induction period and throughout the study period.\n2. Age between 18 and 29 years old (including two-end values, based on the date of signing the Master Informed consent), regardless of gender.\n3. IBS-D patients with clinical symptoms meeting the Rome IV definition, that is, the course of disease for at least 6 months, repeated abdominal pain in the past 3 months, an average of at least 1 day per week, combined with two or more of the following conditions: (a) Abdominal pain is related to defecation; （b） Abdominal pain accompanied by changes in the frequency of defecation; （c） Abdominal pain accompanied by changes in fecal trait. When abnormal stool occurred in the last 3 months, the proportion of abnormal stool was \\>25% for Bristol fecal trait type 6 or 7, and \\\u003C25% for Bristol fecal trait type 1 or 2；and a Hamilton Depression Scale score: 20-34 and\u002For a Hamilton Anxiety Scale score: 14-28 were evaluated as depressed or anxious patients;\n4. Colonoscopy has been completed within 12 months before the run-in period. The ileocecal part should be observed during endoscopy, and the ileocecal flap image recording should be included in the report. They may be included if one of the following conditions is met: (i) The colonoscopy report is normal; (ii) Abnormalities reported by colonoscopy, such as hemorrhoids and intestinal polyps (diameter ≤5mm and number ≤3), were determined by the investigator to be eligible for inclusion; (iii) Colonoscopy reported that the diameter of intestinal polyps was \\>5mm or the number of intestinal polyps was \\>3; after endoscopic treatment, the diameter of residual intestinal polyps was ≤5mm and the number of intestinal polyps was ≤3, and the investigators determined that they could be included in the group.\n5. The patient had not used any relief drugs or analgesics in the 14 days prior to randomization.\n6. During the period from the signing of the master informed consent to the end of the final study visit, patients agreed to maintain their usual diet and lifestyle, such as no changes in dietary structure or exercise patterns.\n\nExclusion Criteria:\n\n1. Patients with constipated, mixed and amorphous IBS.\n2. Patients with organic gastrointestinal diseases were excluded from the following conditions: superficial gastritis, grade I erosive gastritis, chronic atrophic gastritis found by endoscopy but judged by the investigator to be eligible for admission (for example, no mucosal erosion or bleeding under endoscopy, and no abdominal distension, epigastric pain, acid reflux and other symptoms).\n3. Parenteral diseases of the digestive system such as tuberculous peritonitis, pancreatitis, cirrhosis, and biliary tract diseases are present, except for fatty liver disease that has not progressed to hepatitis, and gallstones that lack related symptoms.\n4. Known to have lactose intolerance and celiac disease.\n5. There are other systemic diseases, including serious diseases of the heart, lungs and kidneys, malignant tumors, autoimmune diseases, metabolic diseases (such as diabetes, diseases affecting thyroid function), reproductive system diseases (such as ovarian cysts, endometriosis, severe dysmenorrhea requiring medical treatment), etc.\n6. Previous history of abdominal and pelvic surgery, except appendectomy, caesarean section but no intestinal complications, hernia repair.\n7. Patients with severe mental disorders other than depression and anxiety.\n8. Fecal examination results showed occult blood (+) and above (except for cases caused by hemorrhoids or female menstrual periods) or white blood cells (+) and above, and were judged by the investigator to be clinically significant.\n9. People who are positive for antibodies against hepatitis C virus (HCV), or human immunodeficiency virus (HIV), or syphilis, or hepatitis B surface antigen (HBsAg) and need antiviral therapy at the screening stage.\n10. Laboratory tests showed significant abnormalities, and the investigator determined that the patient's participation in the study may compromise his or her safety, including but not limited to: (i) Creatinine ≥1.5 times the upper limit of normal (ULN); (ii) AST≥2 times upper limit of normal (ULN) and\u002For ALT≥2 times upper limit of normal (ULN) and\u002For total bilirubin ≥1.5 times upper limit of normal (ULN).\n11. A history of drug or alcohol abuse.\n12. Even with the help of liquids, patients are unable to take oral solid dosage forms.\n13. Allergic to experimental drugs, rescue drugs and their ingredients.\n14. During the trial, drugs that affect gastrointestinal movement and function cannot be discontinued, It includes antibiotics (such as erythromycin), drugs that regulate intestinal microecology (such as bifidobacterium), parasympathetic inhibitors (such as scopolamine, atropine, belladona, etc.), muscle relaxants (such as succinylcholine), antidiarrheal agents (such as loperamide, montmorillonite powder, etc.), opioids, drugs that inhibit gastric acid secretion, etc.\n15. A woman who is pregnant or breastfeeding.\n16. At the time of the trial, both the patient and his partner were unable or unwilling to use reliable contraception to prevent pregnancy, or the female or male patient's partner had a recent pregnancy plan.\n17. Have participated in any clinical trial and used the experimental drug or device within 3 months prior to signing the informed consent.\n18. The patient had previously participated in a clinical study of FMT and received FMT therapy.\n19. According to the judgment of the investigator, the participants are not suitable to participate in this clinical trial.","29 Years",{"count":77,"type":19},88,[79],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of Fecal Microbiota Transplantation compared with placebo in the treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D) and Mental Health Comorbidity in Young Adults.",[82,83,84],"Irritable Bowel Syndrome With Diarrhea","Fecal Microbiota Transplantation","Mental Health Issue",[86,83,87,88,89],"Irritable Bowel Syndrome with Diarrhea","Randomized Controlled Study","Mental Health Comorbidity","Young Adults","2024-07-12",{"date":92,"type":30},"2024-07-16",{"date":94,"type":19},"2024-09",{"date":96,"type":19},"2026-06",{"name":36,"class":37},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":20,"phases":108,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100531904","phase-2-efficacy-and-safety-of-fecal-microbiota-transplantation-fmt-in-reducing-recurrence-of-colorectal-adenoma-cra-100531904","NCT06205862","Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Reducing Recurrence of Colorectal Adenoma (CRA)","Efficacy and Safety of Fecal Microbiota Transplantation in Reducing Recurrence of Colorectal Adenomas After Endoscopic Resection: a Multicenter, Open-label, Randomized Controlled Study","Inclusion Criteria:\n\n1. Age 18-75, gender not specified.\n2. Colorectal adenoma patients diagnosed by colonoscopy and treated with endoscopic resection (such as EMR, ESD, APC treatment, etc.)，or patients who have undergone endoscopic resection within the past 6 months and have pathologically confirmed colorectal adenoma.\n3. Individuals who are able to swallow pills\u002Fcapsules.\n4. Individuals who voluntarily sign an informed consent form after fully understanding the purpose and procedures of this study, the characteristics of the disease, the therapeutic efficacy of the drugs, the related examination methods, and the potential risks\u002Fbenefits of the study.\n\nExclusion Criteria:\n\n1. Individuals in whom the adenoma was not completely removed in a previous colonoscopy;\n2. Individuals who experienced serious complications during or after adenoma resection, including perforation, uncontrollable bleeding, or severe infection;\n3. Individuals with a history of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC\u002FLynch syndrome);\n4. Individuals regularly taking aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase 2 (COX2) inhibitors, calcium, or vitamin D;\n5. Individuals with a history of subtotal or total gastrectomy or partial bowel resection;\n6. People who cannot tolerate colonoscopy;\n7. Individuals with allergic diathesis, known allergies to fecal microbiota transplantation, drug allergies, or intolerance;\n8. Individuals with serious heart, liver, or kidney diseases, or any history of cancer;\n9. People suffering from severe constipation;\n10. Pregnant women, breastfeeding mothers, or women planning to become pregnant;\n11. Patients with mental illness who are unable to cooperate;\n12. Individuals involved in the design, planning, or execution of this trial;\n13. Any other individuals who, in the investigator's opinion, are unsuitable for inclusion.","75 Years",{"count":107,"type":19},466,[79],"The goal of this clinical trial is to learn about the efficacy and safety of fecal microbiota transplantation in reducing recurrence of colorectal adenomas after endoscopic resection.\n\nThe main questions it aims to answer are:\n\n* the efficacy and safety of fecal microbiota transplantation in reducing the recurrence rate of colorectal adenomas after endoscopic resection.\n* changes in the intestinal and mucosal microbiota of patients before and after endoscopic treatment.\n* changes in the intestinal and mucosal microbiota of patients before and after fecal microbiota transplantation.\n\nParticipants are required to complete one colonoscopy and infuse 150ml of fecal suspension into the terminal ileum under endoscopy, performing the first fecal microbiota transplantation (FMT) on day 0. Subsequently, for 2 days continuously (day 1-2), the participants will undergo microbiota transplantation in the form of oral capsules, taking 40 FMT capsules within one day (20 capsules bid). Subsequently, participants will receive a maintenance treatment with oral FMT capsules (20 capsules bid) at 3, 6, and 9 months (approximately every 75 to 90 days). Participants will undergo their first follow-up colonoscopy between 6 to 12 months(the high-risk adenoma group will receive colonoscopy at 6 months, and the low-risk adenoma group will receive colonoscopy at 12 months).",[83,111,112],"Colorectal Adenoma","Gastrointestinal Microbiome",[83,114,112,115],"Colorectal Adenomas","Recurrence rate after endoscopic resection",{"date":117,"type":30},"2024-07-15",{"date":119,"type":30},"2024-04-09",{"date":121,"type":19},"2028-12",{"name":36,"class":37},5,""]