The effect of rifaximin in different doses on symptoms and quality of life improvement in Iranian patients with diarrhea-predominant irritable bowel syndrome

Phase 3

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

Registration Number: IRCT20141201020178N11

Lead Sponsor: Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.