[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clostridium-difficile-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clostridium-difficile-infection":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,47,73,101,128,152,178,205],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100641268","phase-1-a-safety-trial-to-evaluate-an-orally-ingested-yeast-modified-to-express-a-tetra-specific-anti-toxin-for-clostridioides-difficile-100641268",false,"NCT07649096","A Safety Trial to Evaluate an Orally Ingested Yeast Modified to Express a Tetra-specific Anti-toxin for Clostridioides Difficile","A Phase 1 Trial to Evaluate an Orally Ingested Probiotic Yeast Genetically Modified to Express a Tetra-specific Anti-toxin for Clostridioides Difficile","Inclusion Criteria:\n\nTo be eligible to participate in Part A of this trial, an individual must meet all of the following criteria:\n\n1. Provides written informed consent prior to the initiation of any trial procedures.\n2. Is able to understand and agrees to comply with all planned trial procedures and be available for all study visits, including:\n\n   1. Receiving 28 days of blinded oral study product\n   2. Providing blood and self-collected stool samples\n3. Is a non-pregnant individual, aged 18-75 years, inclusive, at the time of enrollment.\n4. Has no more than 1 single Grade 1 screening laboratory abnormality that is not clinically significant. If the participant has more than 1 Grade 1 abnormality, it must be approved by the Division of Microbiology and Infectious Diseases \\[DMID\\] Medical Monitor (MM).\n5. Participants of childbearing potential: use of adequate contraception for at least 4 weeks prior to enrollment and agreement to use such a method during trial participation and for an additional 4 weeks after the last dose of blinded study product. Note: Definitions of participants of childbearing potential and adequate contraception are provided in Section 13.1.\n6. Agrees to refrain from ingestion of probiotics\\* or fermented foods\\*\\* from 7 days prior to study product administration, while on blinded study product, and through Day 36 (Visit 6).\n\n   \\*E.g., probiotic nutritional Lactobacillus or Bifidobacterium supplements, yogurt, kefir, any \"live and active culture\" nutritional product, etc.\n\n   \\*\\*E.g., kombucha, fermented pickled vegetables, etc.\n7. Has good health by medical history, vital signs, physical examination, and concomitant medication review\\*. Participants should be stable based on their condition over the last 3 months prior to enrollment.\n\n   \\*As defined by not requiring a change in therapy (including dose or frequency) or medical care for worsening disease for at least 3 months prior to enrollment. Vital signs must not meet Grade 1 or higher.\n8. Not using medications daily that may affect gut motility, gastric acidity, or baseline gut function\\* within 3 months of enrollment and through Day 36 (Visit 6).\n\n   \\*E.g., proton pump inhibitors, opioids, anti-diarrheal agents, anti-constipation agents, daily Over-the-counter \\[OTC\\] \"heartburn\" relief medications.\n9. Not using glucagon-like peptide-1 (GLP-1) receptor agonists within 6 weeks of enrollment.\n10. Any elective surgery (including dental) that required preoperative or postoperative antibiotics must have been completed at least 3 months prior to enrollment.\n11. No history of Clostridioides difficile infection \\[CDI\\] (suspected or proven), no recent hospital admissions (within 3 years), and no receipt of systemic antibiotics known to increase risk of CDI\\* (within 6 months).\n\n    \\*Systemic antibiotics that are known to increase the risk of CDI include lincosamides (e.g., clindamycin), monobactams (e.g., aztreonam), extended-spectrum penicillin combinations with beta-lactamase inhibitors (e.g., piperacillin-tazobactam), carbapenems (e.g., imipenem, meropenem, ertapenem), third generation or higher cephalosporins, and fluoroquinolones. Common oral antibiotics that would be allowable or are not known to significantly increase risk of CDI include amoxicillin, azithromycin, cephalexin, doxycycline, metronidazole, and trimethoprim\u002Fsulfamethoxazole.\n12. No history of other enteric infections or diarrheal illness within 3 months of enrollment.\n\nIn order to be eligible to participate in Part B of this trial, an individual must meet all of the following criteria:\n\n1. Provides written informed consent prior to the initiation of any trial procedures.\n2. Is able to understand and agrees to comply with all planned trial procedures and be available for all study visits, including:\n\n   1. Receiving 28 days of blinded oral study product\n   2. Providing blood and self-collected stool samples\n3. Is non-pregnant individual, aged 18-75 years, inclusive, at the time of enrollment.\n4. Has no more than 1 single Grade 1 hematology result and no more than 1 Grade 1 metabolic panel result. If the participant has more than 1 Grade 1 abnormality, it must be approved by the MM.\n5. Participants of childbearing potential: use of adequate contraception for at least 4 weeks prior to enrollment through 4 weeks after the last dose of blinded study product. Note: Definitions of participants of childbearing potential and adequate contraception are provided in Section 13.1.\n6. To rule out live microbial products and factors that may actively modulate the gut microbiome, participant agrees to refrain from ingestion of probiotics\\* or fermented foods\\*\\* from 7 days prior to study product administration, while on blinded study product, and through Day 36 (Visit 6).\n\n   \\* E.g., probiotic nutritional Lactobacillus or Bifidobacterium supplements, yogurt, kefir, any \"live and active culture\" nutritional product, etc.\n\n   \\*\\* E.g., kombucha, fermented pickled vegetables, etc.\n7. Stable health by medical history, vital signs, physical examination, concomitant medication review, not requiring a change in therapy or medical care for worsening disease within 1 month of enrollment.\n8. Not using medications daily that may affect gut motility, gastric acidity, or baseline gut function\\* within 1 month of enrollment.\n\n   \\*E.g., proton pump inhibitors, opioids, anti-diarrheal agents, anti-constipation agents, daily OTC \"heartburn\" relief medications.\n9. Not using GLP-1 receptor agonists within 6 weeks of enrollment.\n10. Any elective surgery (including dental) that required preoperative or postoperative antibiotics must have been completed at least 1 month prior to enrollment.\n11. Must have had at least 1 of these 3 conditions:\n\n    1. History of CDI (suspected or proven) within the past 3 years, with \"cure\" or no symptoms for at least 1 month prior to enrollment\n    2. History of a hospitalization within the past 3 years, but discharge not sooner than 1 month prior to enrollment\n    3. History of receiving systemic antibiotics known to increase the risk of CDI\\* within the past 3 years, but last dose not sooner than 1 month prior to enrollment \\*Systemic antibiotics that are known to increase risk of CDI include lincosamides (e.g., clindamycin), monobactams (e.g., aztreonam), extended-spectrum penicillin combinations with beta-lactamase inhibitors (e.g., piperacillin-tazobactam), carbapenems (e.g., imipenem, meropenem, ertapenem), third generation or higher cephalosporins, and fluoroquinolones. Common oral antibiotics that would be allowable or are not known to significantly increase the risk of CDI include amoxicillin, azithromycin, cephalexin, doxycycline, metronidazole, and trimethoprim\u002Fsulfamethoxazole.\n12. No history of other enteric infections or diarrheal illness within 1 month of enrollment.\n\nExclusion Criteria:\n\n1. Dwells in a long-term care or skilled nursing facility (living independently with limited nursing care is allowable).\n2. Known to be pregnant or has a positive pregnancy test at screening or enrollment.\n3. Currently breastfeeding a child.\n4. Known to have significant hypersensitivity to any components of the study product; including S. boulardii (or any S. boulardii-based nutritional supplement), hydroxypropyl methylcellulose, and Microcrystalline cellulose \\[MCC\\].\n\n   Hydroxypropyl methylcellulose is the major component of the capsule shell and MCC is the placebo component.\n5. Known to have significant hypersensitivity to a first-line antifungal therapy (i.e., fluconazole or amphotericin B) against Saccharomyces.\n6. Known to be immunocompromised or have known or suspected congenital or acquired immunodeficiency, as determined by the investigator.\n7. Receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 3 years of enrollment.\n8. Receipt of chronic (\\>\u002F=14 days) immunosuppressive corticosteroids at a dose of \\>\u002F=20 mg prednisone daily or prednisone equivalent within 30 days of enrollment, including oral, parenteral, or high-dose inhaled\\* corticosteroids.\n\n   \\*High-dose inhaled corticosteroid is defined as \\>800 mcg\u002Fday of beclomethasone dipropionate CFC or equivalent. Intra-articular, intranasal, and topical steroids are allowable.\n9. Active malignancy or history of malignancy in the past 3 years (non-melanoma, excised, cured skin cancers are allowed).\n10. History of or testing positive for human immunodeficiency virus (HIV), hepatitis B, or active hepatitis C at screening (positive hepatitis C antibody and detectable hepatitis C virus RNA).\n11. Anticipated or current receipt of kidney dialysis treatment.\n12. Concurrent, acutely life-threatening disease or condition, or any unstable medical history, as determined by the investigator.\n13. Significant chronic gastrointestinal \\[GI\\] condition(s) or disease\\*.\n\n    \\*Includes diagnosis of inflammatory bowel disease or active Rome IV irritable bowel syndrome, poorly controlled Celiac disease, active gastroparesis, toxic megacolon, colostomy, intestinal resection (except uncomplicated appendectomy), ileus, short gut syndrome, or recent (within 6 months of enrollment) diverticular bleeding requiring surgical intervention or transfusion.\n14. Recent (within 6 months of enrollment) history of difficulty with swallowing food, liquids, or pills.\n15. Prosthetic heart valve or indwelling foreign structure within vascular supply (e.g., no central line or indwelling catheter) or known to have moderate to severe valvular disease.\n16. History of alcohol abuse or drug addiction within 5 years of enrollment or that might interfere with the ability to comply with trial procedures.\n17. Diagnosis of schizophrenia, bipolar disease, or other significant psychiatric disease in the opinion of the investigator that may interfere with or pose a problem with compliance with the study or the welfare of the participant.\n18. Presence of mild, acute, or self-limited condition, such as fever or cough or other symptoms of upper respiratory tract infection within 7 days prior to planned randomization.\n19. Any chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion or participant safety.\n20. Identified as a study site or contract research organization employee or family member who is involved in the protocol and may have direct access to trial-related data.\n21. Participating in another clinical trial investigating a vaccine, drug, medical device, or medical procedure within 4 weeks of enrollment through the last visit of the study.",true,"ALL","18 Years","75 Years",{"count":21,"type":22},86,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a Phase 1, first-in-human, double-blind, placebo-controlled, adaptive-design, single-site study, involving dose exploration cohorts.\n\nDuring Part A, up to 4 cohorts, each consisting of approximately 14 healthy adult study participants, will be randomly allocated to receive either FZ002 or placebo. Part A is designed to begin with Cohort 1 evaluating the highest proposed dose of study product. This is intended to represent the \"ceiling\" (highest level) of the ranges of doses to be evaluated in the study. In the event of a safety or tolerability concern in Cohort 1, a dose de-escalation will be evaluated in Cohorts 2-4 until a safe and well-tolerated dose is identified. If no safety or tolerability concerns are identified at the completion of a cohort, the study will proceed to Part B with the approval of the independent Safety Monitoring Committee (SMC). This adaptive design allows for the progression of the study from Part A to Part B without necessarily progressing through all 4 cohorts in Part A if there is a lack of safety or tolerability concerns.\n\nDuring Part B, an initial 'sentinel' Cohort 5 \"some-risk\" adult study participants will be randomly allocated to receive a single daily dose of FZ002 or placebo for 28 consecutive days. This is intended to represent the \"floor\" (lowest level) of doses to be evaluated in the study. A Protocol Safety Review Team (PSRT) will review the available safety data from the first 7 days of Cohort 5. If there is a lack of safety or tolerability concerns over the first 7-days of dosing for Cohort 5, then Cohort 6 will be opened for enrollment. Cohort 6 \"some-risk\" adult study participants will evaluate the \"floor\" and \"ceiling\" dose of FZ002 versus placebo.\n\nThe primary objective is to evaluate safety and clinical tolerability of oral doses of FZ002 or placebo when taken for up to 28 days.",[28],"Clostridium Difficile Infection",[30,31,32,33,34],"Clostridioides difficile","Clostridium difficile","Phase 1","Probiotic Yeast","Tetra-specific Anti-toxin","NOT_YET_RECRUITING","2026-06-25",{"date":38,"type":39},"2026-06-26","ACTUAL",{"date":41,"type":22},"2026-06-15",{"date":43,"type":22},"2028-09-22",{"name":45,"class":46},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100328940","outcomes-and-data-collection-for-fecal-microbiota-transplantation-for-the-treatment-of-recurrent-clostridium-difficile-100328940","NCT03562741","Outcomes and Data Collection for Fecal Microbiota Transplantation for the Treatment of Recurrent Clostridium Difficile","Inclusion Criteria:\n\n* Two or more recurrences of C. difficile infection (CDI) with recurrence defined as a positive test result, e.g. Polymerase Chain Reaction (PCR) test and with appropriate symptoms within 2-8 weeks of last positive result, provided that symptoms from earlier episode resolved with or without therapy.\n* Failed standard therapy with oral metronidazole and\u002For oral vancomycin\n* One or more episodes of severe CDI resulting in hospitalization and not responding to standard antibiotic therapy. Hospitalization for CDI occurs in the setting of severe diarrhea, abdominal pain and signs of systemic toxicity\n\nExclusion criteria:\n\n* Age \\\u003C16 years old\n* patients with acute severe colonic dilation at risk for colonic perforation","16 Years",{"count":55,"type":22},500,[57],"NA","The purpose of this study is to see if stool transplant performed by colonoscopy is effective at treating recurrent Clostridium difficile (C. diff) infection of the colon. During the procedure a stool sample is taken from a healthy donor (usually family member or close friend) and transplanted directly into the colon of the patient with C. diff infection. The goal of this experimental procedure (called fecal microbiota transplantation) is to replenish the good bacteria in the colon that can help prevent C. diff infection from coming back after treatment.",[60,28],"Clostridium Difficile Infection Recurrence","RECRUITING","2026-02-18",{"date":64,"type":39},"2026-02-20",{"date":66,"type":39},"2014-01-16",{"date":68,"type":22},"2029-01-16",{"name":70,"class":71},"Krunal Patel","OTHER",1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":80,"targetDuration":82,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100310782","fecal-microbiota-transplant-national-registry-100310782","NCT03325855","Fecal Microbiota Transplant National Registry","FMT","Inclusion Criteria:\n\n* Recipient Inclusion Criteria\n\n  * Ability to give informed consent\n  * Receiving FMT or other gut-related microbiota product within 90 days after providing consent\n  * Access to internet and\u002For telephone\n* Donor Inclusion\n\n  * Ability to give informed consent\n  * Providing stool sample for FMT\n\nExclusion Criteria:\n\n* Incarceration",{"count":81,"type":22},4000,"10 Years","OBSERVATIONAL","A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness",[86,28,87],"Fecal Microbiota Transplantation","Gut Microbiome",[78,89,90],"CDI","Fecal Matter Transplant","2026-01-18",{"date":93,"type":39},"2026-01-21",{"date":95,"type":39},"2017-09-20",{"date":97,"type":22},"2027-08",{"name":99,"class":71},"American Gastroenterological Association",53,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":72},"100609960","phase-2-enteral-vancomycin-as-primary-prophylaxis-against-clostridioides-difficile-infection-in-critically-ill-patients-100609960","NCT07221370","Enteral Vancomycin as Primary Prophylaxis Against Clostridioides Difficile Infection in Critically Ill Patients","Inclusion Criteria:\n\n1. Must meet all 3 criteria:\n\n   * Adults aged 18 years and older.\n   * Receiving ≥ 72 hours of a systemic antibiotic during index hospitalization.\n   * Admitted ≥ 72 hours into their index hospitalization.\n2. And must meet 2 additional of the following high-risk criteria\n\n   * Age ≥ 65 years\n   * Previous residence in long-term care facility\n   * Previous proton pump inhibitor use (chronic or as needed)\n   * Inflammatory bowel disease\n   * Immunocompromised state (HIV\u002FAIDS; transplant recipient; receipt of prednisone 20 mg daily for at least one month, immunosuppressants, or chemotherapy)\n   * End stage renal disease (ESRD)\n   * Diabetes mellitus\n   * Receipt of catecholamines (norepinephrine at a rate of ≥ 5 mcg\u002Fmin)\n   * Hospitalized ≤ 30 days prior to the index hospitalization.\n   * Received systemic antibiotics during that prior hospitalization.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Currently incarcerated individuals\n* Individual or legal representative whose informed consent cannot be obtained\n* Subject not expected to survive the ICU stay or subject likely to be considered for palliative or hospice care\n* Receiving concurrent treatment with metronidazole for any indication\n* One-time empiric use of metronidazole is allowed and does not constitute an exclusion criterion\n* Receiving concurrent probiotics\n* Allergic reaction or had a contraindication for use of enteral vancomycin\n* History of prior CDI within the past 90 days of randomization\n* Had suspected active CDI prior to inclusion\n* Infection requiring more than 14 21 days of systemic antibiotics during index hospitalization",{"count":108,"type":22},176,[110,111],"PHASE2","PHASE3","The goal of this clinical trial is to determine if oral vancomycin can prevent C.diff infection in adults who are critically ill and are at high risk of C.diff infection due to their medical conditions and being in the hospital. It will also help us learn about the safety of the drug in this setting. The main questions the trial aims to answer are:\n\n* Does oral vancomycin lower the rate of C.diff infection in high-risk patients?\n* Does C.diff carrier status change the C.diff infection rate as well as clearance of carrier status when vancomycin is used as primary prophylaxis? Researchers will compare the oral, active drug vancomycin to a placebo (a look-alike substance that contains no drug) to determine if vancomycin works to prevent C.diff infection in the hospital.\n\nParticipants will:\n\n* Take oral vancomycin or a placebo while they receive systemic antibiotic(s) for up to five days after the last dose of said systemic antibiotic(s). The treatment of said systemic antibiotic(s) is not to exceed 21 days.\n* When discharged from the hospital, participants will continue to take the study medication in the event he\u002Fshe did not complete the intended course of the study medication while in the hospital.\n* Participants will provide stool sample or rectal swabs for to assess their C.diff carrier status as well as any change in stool microbiome status, including VRE (vancomycin resistant Enterococcus)\n* After completion of the intervention period, participants will be contacted via telephone to assess if they developed diarrhea or any untoward effects of study medication.",[28,114],"Vancomycin Resistant Enterococci Infection",[116,117,118],"Clostridium difficle infection","primary prophylaxis","Vancomycin resistant enterocci infection","2025-11-05",{"date":121,"type":39},"2025-11-10",{"date":123,"type":39},"2024-10-21",{"date":125,"type":22},"2026-12-31",{"name":127,"class":71},"Riverside University Health System Medical Center",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":137,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":72},"100201977","fecal-microbiota-transplantation-for-c-diff-infection-100201977","NCT01905709","Fecal Microbiota Transplantation for C Diff Infection","Fecal Microbiota Transplantation for the Treatment of Recurrent or Refractory Clostridium Difficile Infection (CDI)","Inclusion Criteria:\n\n1. Subject is at least 18 years old.\n2. Subject has recurrent or relapsing CDI defined as:\n\n   * At least three episodes of mild-to-moderate CDI and failure of a 6-8 week taper with vancomycin with or without an alternative antibiotic (e.g., rifaximin, nitazoxanide, fidaxomicin). OR\n   * At least two episodes of severe CDI resulting in hospitalization and associated with significant morbidity. OR\n   * Moderate CDI not responding to standard therapy (vancomycin) for at least a week. OR\n   * Severe C. difficile infection with toxic megacolon, not responding to standard therapy or the use of IVIg.\n3. Subject is willing and able to provide informed consent.\n4. If a female of childbearing potential, subject has agreed to use an acceptable form of birth control for up to 4 weeks after FMT treatment.\n\nExclusion Criteria:\n\n1. Subject is pregnant.\n2. Subject is unable to comply with study requirements.",{"count":136,"type":22},100,[57],"The objective of this study is to provide treatment with Fecal Microbiota Transplantation (FMT) to patients with recurrent or refractory Clostridium difficile infection (CDI). It has been shown that good bacteria (like that found in the stool from a healthy donor) attack Clostridium difficile in multiple ways: they make substances that kill Clostridium difficile - and they attach to the surface of the colon lining, which prevents the Clostridium difficile toxin (poison) from attaching.\n\nFMT involves infusing a mixture of saline and stool from a healthy donor into the bowel of the patient with CDI during a colonoscopy.\n\nThe method used to deliver the FMT will depend on individual characteristics of the subject and is at the discretion of the treating physician. FMT may be administered by the following methods.\n\n* Colonoscopy: This method allows full endoscopic examination of the colon and exclusion of comorbid conditions (such as IBD, malignancy or microscopic colitis) which may have an impact on subject's treatment or response to therapy.\n* Sigmoidoscopy: This method still allows infusion of the stool into a more proximal segment of the colon than an enema, but may not require sedation. This method may be beneficial in subjects who are elderly or multiparous and who may have difficulty retaining the material when given as enema. Sigmoidoscopic administration eliminates the additional risks associated with colonoscopy in subjects who may not have a clear indication for colonoscopy.\n* Retention enema: This method may be preferable in younger subjects who have already had recent endoscopic evaluation, in subjects who prefer not to undergo endoscopy or in subjects with significant co morbidities and may not tolerate endoscopy.\n\nThe physician will administer 300-500 mL of the fecal suspension in aliquots of 60 mL, through the colonoscope or sigmoidoscope or 150 mL via retention enema. In cases of colonoscopic delivery, the material will be delivered to the most proximal point of insertion.\n\nThe subject is encouraged to retain stool for as long as possible.",[28],[141,89,142],"C diff","clostridium difficile associated diarrhea","2025-04-11",{"date":145,"type":39},"2025-04-13",{"date":147,"type":4},"2013-07",{"date":149,"type":22},"2026-12",{"name":151,"class":71},"Englewood Hospital and Medical Center",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":17,"minAge":159,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":163,"conditions":164,"keywords":165,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":72},"100570182","study-on-clostridium-difficile-infection-in-infants-100570182","NCT06703918","Study on Clostridium Difficile Infection in Infants","A Retrospective Cohort Study on the Epidemiological Characteristics and Biomarkers of Clostridium Difficile Infection in Infants","Inclusion Criteria:\n\n* Infants ( aged 0-2 years). Medical records and patient questionnaires available with confirmed Clostridium difficile infection (for case group) or without infection (for control group).\n\nExclusion Criteria:\n\n* Infants beyond the age of 2 years at the time of diagnosis. Incomplete medical records or missing essential information related to infection status, feeding methods, or antibiotic exposure.Patients with other severe gastrointestinal conditions that may confound results.","0 Months","24 Months",{"count":162,"type":22},150,"This study aims to investigate the epidemiological characteristics and biomarkers of Clostridium difficile infection in infants . By analyzing historical medical data and patient questionnaires, this retrospective cohort study will identify potential high-risk factors and establish baseline biomarkers to improve diagnosis and treatment for affected patients.",[28],[31,166,167,168],"Infants","Epidemiology","Biomarkers","2024-11-21",{"date":171,"type":39},"2024-11-25",{"date":173,"type":39},"2024-07-01",{"date":175,"type":22},"2026-12-30",{"name":177,"class":71},"First People's Hospital of Hangzhou",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":23,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":204},"100385980","phase-2-alanyl-glutamine-supplementation-for-c-difficile-treatment-act-100385980","NCT04305769","Alanyl-glutamine Supplementation for C. Difficile Treatment (ACT)","Alanyl-glutamine Supplementation of Standard Treatment for C. Difficile Infection: a Randomized, Double-blind, Placebo-controlled Trial","ACT","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 18 years and older.\n4. Admitted to UVA hospital, or seen as an outpatient, or seen at Carilion hospital.\n5. Presence of diarrhea\\*\n6. Episode of C. difficile infection, non-severe or severe uncomplicated.\n7. Within 120 hours of receiving standard therapy (oral vancomycin or fidaoxmicin).\n8. Must be able to provide informed consent in person or electronically, or if not able to have a LAR to provide consent, in person or remotely via virtual or electronic means.\n\nExclusion Criteria:\n\n1. At enrollment, presence of any of the following:\n\n   1. Hypotension or shock\n   2. Megacolon or moderate to severe ileus\n   3. Acute abdomen\n   4. Admission to intensive care unit\n2. Inability to tolerate oral or enteral medication\n3. Presence of other known infectious etiology of diarrhea\n4. COVID-19 co-infection at the time of CDI diagnosis.\n5. Absolute neutrophil count \\\u003C500 mcl\n6. Within 100 days of hematologic or solid organ transplant\n\n   • Inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) or other etiology of non-infectious diarrhea. For patients with history of IBD, allow enrollment if disease is well-controlled and stable (not in flare).\n7. Enrollment in another investigational drug trial\n8. Current use of alternative treatment for CDI (e.g. antibiotics other than vancomycin or fidaxomicin; IVIg; fecal transplant).\n9. On probiotics and not willing to discontinue.\n10. Cirrhosis or in participants with ALT \\> 3X normal\n11. End stage renal disease, unless on dialysis(HD or PD) or creatinine clearance or estimated GFR of \\\u003C30mL\u002Fmin even after adequate hydration\n12. Life expectancy of \\\u003C 6 months.","105 Years",{"count":188,"type":22},260,[110],"This is a randomized, double-blind, placebo-controlled trial to determine the optimal dose and safety of oral alanyl-glutamine between 4, 24, and 44 g doses administered for 10 days with standard therapy among first time incident cases of uncomplicated C. difficile infection (CDI) in hospitalized, or outpatient, persons aged 18 or older. The investigators hypothesis is that alanyl-glutamine supplementation will decrease recurrence and mortality from CDI and these outcomes will be associated with improvement of inflammatory markers and restoration of intestinal microbiota function.",[192,28,193,194],"Clostridioides Difficile Infection","Clostridium Difficile Diarrhea","Clostridia Difficile Colitis","2024-10-22",{"date":197,"type":39},"2024-10-26",{"date":199,"type":39},"2021-06-01",{"date":201,"type":22},"2027-06-30",{"name":203,"class":71},"University of Virginia",2,{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":23,"phases":214,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":72},"100363607","safety-and-efficacy-of-fecal-microbiota-transplantation-100363607","NCT04014413","Safety and Efficacy of Fecal Microbiota Transplantation","Safety and Efficacy of Fecal Microbiota Transplantation: A Pilot Study","Inclusion Criteria:\n\nConfirmed diagnosis of any of the following diseases:\n\n* Crohn's disease\n* Ulcerative colitis\n* Celiac disease\n* Irritable bowel syndrome\n* Functional dyspepsia\n* Constipation\n* Antibiotic-associated diarrhea or any antibiotic- associated complications\u002Fsymptoms\n* Metabolic syndrome such as diabetes mellitus and obesity\n* Multidrug-resistant infection\n* Hepatic encephalopathy\n* Multiple sclerosis\n* Pseudo-obstruction\n* Carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococci (VRE) infection\n* Multiple organ dysfunction\n* Dysbiotic bowel syndrome\n* MRSA enteritis\n* Pseudomembranous enteritis\n* Alopecia, autism\n* Graft-versus-host disease\n* Idiopathic thrombocytopenic purpura (ITP)\n* Atopy or allergy\n* Liver disease such as Nonalcoholic fatty liver disease (NAFLD) and Nonalcoholic steatohepatitis (NASH)\n* Alcohol dependence\n* Psoriatic arthropathy that has suboptimal control of disease despite standard treatment.\n\nExclusion Criteria:\n\n* Known contraindication to all FMT infusion method such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy and enema\n* Any conditions that may render the efficacy of FMT or at the discretion of the investigators\n* Current pregnancy",{"count":213,"type":22},450,[57],"The gut microbiota is critical to health and functions with a level of complexity comparable to that of an organ system. Dysbiosis, or alterations of this gut microbiota ecology, have been implicated in a number of disease states. Fecal microbiota transplantation (FMT), defined as infusion of feces from healthy donors to affected subjects, is a method to restore a balanced gut microbiota and has attracted great interest in recent years due to its efficacy and ease of use. FMT is now recommended as the most effective therapy for CDI not responding to standard therapies.\n\nRecent studies have suggested that dysbiosis is associated with a variety of disorders, and that FMT could be a useful treatment. Randomized controlled trial has been conducted in a number of disorders and shown positive results, including alcoholic hepatitis, Crohn's disease (CD), ulcerative colitis (UC), pouchitis, irritable bowel syndrome (IBS), hepatic encephalopathy and metabolic syndrome. Case series\u002Freports and pilot studies has shown positive results in other disorders including Celiac disease, functional dyspepsia, constipation, metabolic syndrome such as diabetes mellitus, multidrug-resistant, hepatic encephalopathy, multiple sclerosis, pseudo-obstruction, carbapenem-resistant Enterobacteriaceae (CRE) or Vancomycin-resistant Enterococci (VRE) infection, radiation-induced toxicity, multiple organ dysfunction, dysbiotic bowel syndrome, MRSA enteritis, Pseudomembranous enteritis, idiopathic thrombocytopenic purpura (ITP), and atopy.\n\nDespite FMT appears to be relatively safe and efficacious in treating a wide range of disease, its safety and efficacy in a usual clinical setting is unknown. More data is required to confirm safety and efficacy of FMT. Therefore, the investigators aim to conduct a pilot study to investigate the efficacy and safety of FMT in a variety of dysbiosis-associated disorder.",[217,218,219,220,221,222,28,223,224,225,226,227,228,229,114,230,231,232,233,234,235,236,237,238,239,240,241],"Crohn Disease","Ulcerative Colitis","Celiac Disease","Irritable Bowel Syndrome","Functional Dysphonia","Constipation","Diabetes Mellitus","Obesity","Multidrug -Resistant Infection","Hepatic Encephalopathy","Multiple Sclerosis","Pseudo-Obstruction","Carbapenem-Resistant Enterobacteriaceae Infection","Multiple Organ Dysfunction Syndrome","Dysbiotic Bowel Syndrome","MRSA Enteritis","Pseudomembranous Enterocolitis","Alopecia","Autism","Graft-versus-host Disease","Idiopathic Thrombocytopenic Purpura","Atopy or Allergy","Liver Disease","Alcohol Dependence","Psoriatic Arthropathy","2024-08-21",{"date":244,"type":39},"2024-08-22",{"date":246,"type":39},"2019-07-15",{"date":248,"type":22},"2030-10-31",{"name":250,"class":71},"Chinese University of Hong Kong"]