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IRCT20141201020178N11 IRCT 2022-04-03 Iran University of Medical Sciences The effect of rifaximin in different doses on symptoms and quality of life improvement in Iranian patients with diarrhea-predominant irritable bowel syndrome A comparison between the effect of rifaximin in different doses on symptoms and quality of life improvement in Iranian patients with diarrhea-predominant irritable bowel syndrome, a randomized clinical trial. 2022-01-21 anticipated 200 Complete https://irct.ir/trial/62482 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: computer-generated ,simple randomization with interactive web response system(IRS) into two equally-numbered groups. 3 diarrhea predominant irritable bowel syndrome. Intervention 1: Control group: 550mg capsule of rifaximin twice a day. Intervention 2: Intervention group: 550mg capsule of rifaximin three times in a day. 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 No more data existed
public Marjan Mokhtare
Niayesh Street, Sattarkhan Street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6655 4790 marjanmokhtare@yahoo.com Iran University of Medical Sciences scientific Marjan Mokhtare
Satarkhan Avenue,Niayesh street
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6652 2845 marjanmokhtare@yahoo.com Iran University of Medical sciences, Rasoul Akram Hospital, Colorectal Research Center Iran (Islamic Republic of) Diarrhea-dominant IBS (IBS-D) patients Patients who are able to follow the study protocol Patients who are available for the entire study period Women and men amongst Iranian population 16-70 years old patients 16 years 70 years Both All patients with other subclass of IBS Probiotics consumption in the last 3 months Antibiotic therapy in the last 3 months Concomitant systemic disease (malignancy, uncontrolled hypertension, diabetes mellitus, liver, kidney, pulmonary or heart diseases, neurological disorders, psychosis, thyroid dysfunction, lactose intolerance, pregnancy or breastfeeding, inflammatory bowel disease, celiac disease, and gastroduodenal disease) Taking fiber supplements within 2 weeks before starting the study Planning to have surgery during the study time History of alcohol or drug abuse Participating in another clinical trial over the past three months Positive PCR result for covid 19 K58.0 Irritable bowel syndrome with diarrhea Treatment - Drugs Treatment - Drugs Control group: 550mg capsule of rifaximin twice a day Intervention group: 550mg capsule of rifaximin three times in a day Comparison of improvement in IBS-D patients symptom severity index between treatment groups. Timepoint: At the beginning of treatment, at the end of treatment, 4 and 8 weeks after completing treatment. Method of measurement: IBS-D symptom severity index questionnaire. Comparison of improvement in IBS-D patients quality of life between treatment groups. Timepoint: At the beginning of treatment, at the end of treatment, 4 and 8 weeks after completing treatment. Method of measurement: IBS-D quality of life questionnaire. Comparison of improvement in quality of life. Timepoint: At the beginning, at the end of treatment, 4 and 8 weeks after end of the treatment. Method of measurement: Bristol stool texture score. Comparison of improvement in IBS-D anxiety and depression score. Timepoint: At the beginning and end of the treatment. Method of measurement: Beck depression and anxiety score. Iran University of Medical Sciences Approved 2021-06-19 Ethics committee of iran university of medical science Iran University of Medical Sciences, West Shahid Hemmat Highway,Intersection of Chamran and Sheikh Fazlollah Noori tehran Tehran Iran (Islamic Republic of)