diarrhea-predominant irritable bowel syndrome. Irritable bowel syndrome with diarrhea
Conditions
Interventions
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.
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
16 Years to 70 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMarjan Mokhtare
Iran University of Medical Sciences
Outcome results
None listed