[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ibs-d-diarrhea-predominant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ibs-d-diarrhea-predominant":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100637804","phase-4-effect-of-ramosetron-in-patients-with-diarrhea-predominant-irritable-bowel-syndrome-100637804",false,"NCT07574320","Effect of Ramosetron in Patients With Diarrhea Predominant Irritable Bowel Syndrome","Effect of Ramosetron in Patients With Diarrhea Predominant Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Study","Inclusion Criteria:\n\n* Adults aged 18-65 years.\n* Patients fulfilling Rome IV diagnostic criteria for IBS-D.\n* Willing to provide informed written consent.\n* Patients able to attend regular follow-up visits during the study period.\n\nExclusion Criteria:\n\n* Presence of alarm features: anemia, weight loss, per rectal bleeding, nocturnal frequency, and family history of colonic cancer or inflammatory bowel disease\n* History of major gastrointestinal surgery (excluding appendicitis )\n* Recent antibiotic use within 4 weeks\n* Patient with uncontrolled diabetes, hyperthyroidism, hypothyroidism\n* Pregnant or lactating women\n* Drug abuse or alcohol abuse","ALL","18 Years","65 Years",{"count":20,"type":21},76,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Irritable bowel syndrome (IBS) tends to be a lifelong disorder and it is often frustrating to both patients and physicians. This study aim of improving symptom control, reducing healthcare burden and upgrading the quality of life of patient with diarrhea predominant IBS-D.\n\nPatients of both sex of age group 18-65 years attending gastroenterology outpatient department Dhaka Medical College Hospital (DMCH) meeting the inclusion criteria of Diarrhea predominant irritable bowel syndrome (IBS-D) will be initially enrolled for the study. Their history, clinical examination \\& initial investigations will be done. Report will be noted in the standard data sheet. Any alternative diagnosis if proven by clinical examination or laboratory investigation will be excluded from the study.\n\nEach patient will go through a run-in period of 7 days. Number of subjects will be recruited according to sample size. Randomization into two groups will be performed by online randomizer websites.\n\nOne group will receive tablet ramosetron 2.5 mcg one time daily at morning before breakfast while the other group will receive identical looking placebo one tablet once daily at same time. Both groups will be adviced for low FODMAP diet along with lifestyle modification. The tablets will be administered for total 4 weeks. Before starting treatment, each individual will undergo a baseline assessment during which demographic data, base line investigations, IBS symptoms by IBS Symptom Severity Score (IBS-SSS) will be recorded. Patients will be followed-up after 4 weeks and 8 weeks by IBS-SSS questionnaire. Any adverse effect will be reported quickly and documented at the same time.\n\nIBS-SSS is a 5 item tools. It is primarily measures the IBS symptoms which includes abdominal pain and distension as well as bowel satisfaction. This scale evaluates IBS symptoms: abdominal pain, abdominal distension, stool frequency and consistency and interference with life in general. The IBS-SSS calculates the sum of these 5 items scored on a visual analogue scale from 0-100.",[27],"IBS-D (Diarrhea-predominant)",[29,30,31,32],"IBS-D","Diarrhea Predominant Irritable Bowel Syndrome","Ramosetron","IBS-SSS","NOT_YET_RECRUITING","2026-05-04",{"date":36,"type":37},"2026-05-07","ACTUAL",{"date":39,"type":21},"2026-04-30",{"date":41,"type":21},"2027-02-01",{"name":43,"class":44},"Md. Aminul Islam","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100571989","phase-2-efficacy-of-rifaximin-with-nac-in-ibs-d-100571989","NCT06727422","Efficacy of Rifaximin With NAC in IBS-D","A Phase 2b, Randomized, Double-Blind, Placebo- Controlled, Multicenter Study to Assess the Safety, Efficacy and Pharmacokinetics of RNIB21 in the Treatment of Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)","Inclusion Criteria:\n\n1. Male or non-pregnant, non-lactating female patients ≥ 18 years of age\n2. Diagnosed with IBS confirmed by the Rome IV criteria, with associated symptoms of diarrhea as noted below in 4(b).\n3. Do not have adequate relief of IBS symptoms of abdominal pain, stool consistency or stool frequency\n4. Have daily IBS symptom scores during screening as below:\n\n   1. Weekly average score of worst daily abdominal pain \\>3.0 on a 0-10 point scale\n   2. At least one stool with a consistency of Type 6 or 7 on the Bristol\n\nExclusion Criteria:\n\n1. Present with the following symptoms of IBS with constipation:\n\n   1. Less than 3 bowel movements a week,\n   2. Hard or lumpy stools, and\n   3. Excessive straining during a bowel movement.\n2. History of inflammatory bowel disease, celiac disease, GI surgery (except cholecystectomy and\u002For appendectomy)\n3. Evidence of active duodenal ulcer, gastric ulcer, diverticulitis, or active infectious gastroenteritis\n4. Current diagnosis of asthma\n5. Current user of NAC and\u002For rifaximin\n6. Systemic antibiotic use in the last month\n7. Not currently on a prokinetic drug\n8. A significant medical condition including but not limited to hepatic, uncontrolled diabetes, renal, cardiovascular, pulmonary, uncontrolled thyroid disease. or psychiatric disease, which in the opinion of investigator precludes study participation",{"count":53,"type":21},225,[55],"PHASE2","The purpose of this study is to examine the effectiveness of using a combination of a drug, rifaximin and a dietary supplement, N-acetyl-L-cysteine (NAC), to treat patients with irritable bowel syndrome with diarrhea (IBS-D). Rifaximin is one of the standard treatments for IBS-D and is FDA approved. While rifaximin is safe and effective for treating symptoms in patients with IBS-D, many patients find that their symptoms may not completely resolve, or may come back after a period of time.\n\nThis research study is designed to test the investigational use of a combination of rifaximin and NAC. The combination of rifaximin and NAC is not approved by the U.S. Food and Drug Administration (FDA) for the treatment of IBS-D, and the effects of taking both medications together are unknown. However, the two medications are approved for use separately, as detailed below.\n\nRifaximin is the only antibiotic approved by the FDA for the treatment of IBS-D. Rifaximin (at a dose of 550 mg by mouth three times daily for 14 days) is approved by the FDA for the treatment of IBS-D. Rifaximin (at a dose of 200 mg per mouth three times daily for 3 days) is FDA approved for the treatment of traveler's diarrhea. Rifaximin at a dose of 200 mg per mouth three times daily is not approved by the FDA for the treatment of IBS-D.\n\nNAC is approved by the FDA to treat acetaminophen overdose (72-hour oral and 21-hour intravenous (IV) regimens), and for use in breaking up mucus in the lungs in patients with chronic obstructive pulmonary disease (COPD) and other lung conditions such as bronchitis. NAC is also available over-the-counter in 600 mg and 900 mg capsules as a dietary supplement, although over-the-counter use is not regulated by the FDA. This study will utilize the 600 mg dietary supplement capsules.\n\nThe Investigators want to know if using a combination of rifaximin and NAC will give better results in decreasing IBS-D symptoms than using rifaximin alone. As NAC is used to break up mucus in the lungs, and the Investigators want to see if this can also break up the mucus layer in the small intestine, and therefore potentially increase the effectiveness of rifaximin. The Investigators will be testing 2 doses to determine which dose is most effective.\n\nparticipants are being asked to take part in this research study because participants were diagnosed with IBS-D.",[58,27],"IBS (Irritable Bowel Syndrome)",[29],"RECRUITING","2026-04-16",{"date":63,"type":37},"2026-04-20",{"date":65,"type":37},"2026-02-04",{"date":67,"type":21},"2027-01-01",{"name":69,"class":44},"Mark Pimentel, MD",1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100605892","phase-3-saccharomyces-boulardii-cncm-i-745-in-irritable-bowel-syndrome-100605892","NCT07168434","Saccharomyces Boulardii CNCM I-745 in Irritable Bowel Syndrome","A Double-blind, Randomized, Placebo-controlled, Multicenter Trial Evaluating the Efficacy and Safety of Saccharomyces Boulardii CNCM I-745 in Adult Patients With Non-constipated Irritable Bowel Syndrome","BoWell Sb252","Inclusion Criteria:\n\n1. Male or female aged ≥ 18 and ≤ 65 years.\n2. Diagnosis of IBS of any subtype, except constipation predominant (IBS-C), according to Rome IV criteria.\n3. IBS-SSS total score ≥ 175 at inclusion.\n4. Able and willing to maintain their nutrition habits throughout the study participation.\n5. Able to understand and willing to comply with study requirements and to provide written informed consent.\n6. For women of childbearing potential: willing to use one or more acceptable birth control method throughout the study participation.\n\nExclusion Criteria:\n\n1. Diagnosis of IBS-C according to Rome IV criteria.\n2. Patient with more than 5 bowel movements per day on average during the screening period, according to the patient's diary (BSFS).\n3. Severe illness(es) or medical condition(s), including gastrointestinal pathologies (other than IBS): gastrointestinal ulcers, coeliac disease, inflammatory bowel disease, bowel cancer, acute or chronic diarrhea secondary to confirmed infectious gastroenteritis, or enteral or parenteral nutrition.\n4. History of abdominal surgery (except for appendectomy, cholecystectomy, surgery for hemorrhoids or cesarian section, more than 6 months prior to inclusion).\n5. Familial colorectal cancer syndrome (Lynch, Familial Adenomatous Polyposis).\n6. Fecal transplant within 6 months prior to screening.\n7. Use of products marketed as prebiotics, probiotics or synbiotics within 2 weeks prior to screening. These products, with the exception of the investigational product, will not be allowed during the trial. Regular cheese or yogurt containing lactic acid bacteria are not an exclusion criterion.\n8. Systemic antibiotic or antimycotic treatment within 2 weeks prior to randomization. These treatments are not allowed during the study.\n9. Laxatives, antibloating agents, antidiarrheal medication, antispasmodics, within 2 weeks prior to screening. These treatments are not allowed during the study, except loperamide which can be used as rescue medication.\n10. Daily or regular non-steroidal anti-inflammatory drugs (NSAIDS) at doses above cardiovascular prophylaxis (low dose aspirin) are not allowed within 2 weeks prior to screening and throughout the study participation.\n11. Use of opioids or narcotic analgesics, including tramadol and codeine, within 6 weeks prior to screening. These treatments are not allowed during the study.\n12. Treatment with two or more antidepressant\u002Fanxiolytic\u002Fantipsychotic within 3 months prior to study entry or during the trial. Treatment with a single antidepressant or anxiolytic or antipsychotic agent before and during the trial is allowed provided that the dose is stable within 3 months prior to study entry and during the trial participation.\n13. Treatment with anticholinergics for overactive bladder such as solifenacin, darifenacin, oxybutynin, tolterodine, fesoterodin, propiverin, trospium chloride, or mirabegron, within 1 week prior to screening. These treatments are not allowed during the study.\n14. Allergy to yeast, especially Saccharomyces boulardii, or known hypersensitivity to one of the components.\n15. Patients having a central venous catheter, critically ill patients, and immunocompromised patients.\n16. Patients with rare hereditary problems of galactose or fructose intolerance, total lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.\n17. Excessive alcohol consumption (\\>7 units\u002Fweek) and\u002For drug abuse.\n18. Other medical conditions or comorbidities, treatment, which in the opinion of the investigator, would interfere with study compliance or data interpretation.\n19. Presenting any significant biological or clinical anomalies that are not compatible with participation in the study according to the investigator.\n20. Participant at risk of pregnancy, pregnant or breastfeeding female.\n21. Participant under guardianship or curatorship.\n22. Participant under the protection of the Court or deprived of liberty.\n23. Participant participating in another interventional clinical trial which could interfere with the trial's results or impact the other trial's results; or within 5 half-lives of the study investigational treatment, whichever is longer.\n24. Participant whose current state of health does not allow him\u002Fher to give consent.",{"count":80,"type":21},406,[82],"PHASE3","This is a double-blind, randomized (group assignment by chance), placebo-controlled, multicenter trial which will be conducted over a 13.5-months period The main objective of the research is to demonstrate the efficacy of Saccharomyces boulardii CNCM I-745 on global IBS symptoms, measured by the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS), in comparison to placebo after 8 weeks.\n\nSecondary efficacy objectives are to evaluate the impact of Saccharomyces boulardii CNCM I-745 on quality of life of IBS patients and on global and individual IBS symptoms, using the IBS-SSS, in comparison to placebo at regular intervals over a 3-month treatment period. This research also aims to evaluate the proportion of patients who improved ≥ 50 points on IBS-SSS and the proportion of responders according to the European Medicines Agency (EMA) definition (based on the patient's global assessment of efficacy and on abdominal pain score), after 8 weeks of treatment. Secondary safety objective is to evaluate the safety profile and tolerability of Saccharomyces boulardii CNCM I-745 capsules 500 mg\u002Fday in IBS patients in comparison to placebo",[58,27,85],"IBS, Mixed Symptoms",[87,88,89,90],"IBS","Irritable Bowel Syndrome","Saccharomyces boulardii","Non-constipated IBS","2025-11-17",{"date":93,"type":37},"2025-11-18",{"date":95,"type":37},"2025-10-22",{"date":97,"type":21},"2026-10-11",{"name":99,"class":100},"Biocodex","INDUSTRY",10]