The therapeutic effects of rifaximin in diarrhea-predominant irritable bowel syndrome

Phase 3

Conditions: diarrhea-predominant irritable bowel syndrome.
Irritable bowel syndrome with diarrhea
K58.0

Registration Number: IRCT20141201020178N12

Lead Sponsor: Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.