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IRCT20141201020178N12 IRCT 2023-08-31 Iran University of Medical Sciences The therapeutic effects of rifaximin in diarrhea-predominant irritable bowel syndrome Comparison of effectiveness of rifaximin at doses of 1650mg and 2200mg in the treatment of patients with diarrhea-predominant irritable bowel syndrome. 2023-07-23 anticipated 150 Complete https://irct.ir/trial/70701 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Computer-generated, simple randomization with SPSS software into two equally numbered groups. After recruiting the eligible subjects and dedicating distinctive IDs to each patient, patients will be randomly allocated into two equal groups using the randomization command in SPSS software. 3 diarrhea-predominant irritable bowel syndrome. Intervention 1: Control group: 550mg capsule of rifaximin three times a day for 10 days. Intervention 2: Intervention group: 550mg capsule of rifaximin four times a day for 10 days. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is not decided yet / needs all authors' approval
public Marjan Mokhtare
Sattarkhan Street; Niayesh Street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 4790 marjanmokhtare@yahoo.com Iran University of Medical Sciences scientific Marjan Mokhtare
Sattarkhan Street; Niayesh Street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6652 2845 marjanmokhtare@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Diarrhea-dominant irritable bowel syndrome (IBS-D) patients based on ROME IV criteria Patients who are available for the entire study period Women and men among Iranian population with more than 16 years old Patients who are able to follow the study protocol 16 years 70 years Both Mild IBS-D (less than 175 points on the IBS-SSS scale) All IBD subtypes Consumption of Antibiotics or probiotics in the past three months before trial A severe concomitant disease (malignancy, hypertension uncontrolled and diabetes mellitus, liver, kidney or heart disorders, serious neurological disorders, psychosis, respiratory disorders such as asthma, chronic obstructive pulmonary disease, hyperthyroidism or hypothyroidism) Diagnosed lactose intolerance Consumption of motility medications or dietary fiber supplements 2 weeks before the start of the study Planning to undergo surgery during the study period History of alcohol or drug abuse Chronic bowel disorders other than IBS, including inflammatory bowel disease, gastric and duodenal ulcers, celiac disease Participation in another clinical trial within the past three months Positive PCR result for the COVID-19 Pregnancy or breastfeeding K58.0 Irritable bowel syndrome with diarrhea Treatment - Drugs Treatment - Drugs Control group: 550mg capsule of rifaximin three times a day for 10 days Intervention group: 550mg capsule of rifaximin four times a day for 10 days Abdominal pain. Timepoint: Before the treatment, at the end of treatment, 4 and 8 weeks after completing treatment. Method of measurement: IBS-D symptom severity index questionnaire. Bloating. Timepoint: Before the treatment, at the end of treatment, 4 and 8 weeks after completing treatment. Method of measurement: IBS-D symptom severity index questionnaire. Defecation frequency/urgency. Timepoint: Before the treatment, at the end of treatment, 4 and 8 weeks after completing treatment. Method of measurement: IBS-D symptom severity index questionnaire. Quality of life. Timepoint: Before and after the treatment course. Method of measurement: IBS-D quality of life questionnaire. Stool consistency. Timepoint: Before the treatment, at the end of treatment, 4 and 8 weeks after completing treatment. Method of measurement: bristol stool form scale. Safety. Timepoint: At the end of treatment, 4 and 8 weeks after completing treatment. Method of measurement: recorded by physicians and patients using data gathering sheets. Tolerability. Timepoint: At the end of treatment, 4 and 8 weeks after completing treatment. Method of measurement: Recorded by physicians and patients using data gathering sheets. Iran University of Medical Sciences Approved 2023-06-11 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, West Shahid Hemmat Highway, Intersection of Chamran and Sheikh Fazlollah Noori Tehran Tehran Iran (Islamic Republic of)