Hydrogen Breath Test an Instrument to Predict Rifaximin-Response in Irritable Bowel Syndrome Predominant Diarrhea

NCT ID: NCT03729271

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-09
• Study Completion Date: 2026-01-01

Brief Summary

The purpose of this study is to learn more about how to improve treatment of patients with diarrhea predominant Irritable Bowel Syndrome (IBS-D) symptoms.Included patients will be requested to answer online surveys and will undergo treatment with rifaximin. Hydrogen breath testing and biologic samples collection will also be completed during the study.

Detailed Description

The study aims to determine whether hydrogen breath testing can be used to identify patients with IBS-D who are more likely to respond to rifaximin. Participating patients will complete a one week screening period when brief daily survey will be answered. Eligible patients will proceed with the treatment phase of the study, when patients will receive a 14 day course of rifaximin. All included patients will complete glucose and lactulose hydrogen breath tests before and after rifaximin treatment. Biological samples (e.g. blood, stool) will be collected at pre-determined time points and patients will answer daily brief survey for the duration of the study.

It is anticipated that 210 patients will be screened to reach a goal of enrolling 175 patients for the treatment phase of the study.

Conditions

Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rifaximin and breath tests

Rifaximin 550mg three times a day for 14 days. Breath tests (glucose and lactulose) will be completed prior to Rifaximin treatment and at week 13 of the study.

Group Type: EXPERIMENTAL

Rifaximin

Intervention Type: DRUG

Rifaximin will be given during weeks 2-4

Glucose and lactulose hydrogen breath testing

Intervention Type: DEVICE

Subjects will undergo glucose and lactulose hydrogen breath tests for Small Intestinal Bacterial Overgrowth (SIBO) on consecutive days using a commercially available home base kits (Glucose Hydrogen Breath Test Collection Kit and Lactulose Hydrogen Breath Test Collection Kit for SIBO from Commonwealth Diagnostic International) prior to Rifaximin treatment and at week 13 of the study.

Interventions

Rifaximin

Rifaximin will be given during weeks 2-4

Intervention Type: DRUG

Glucose and lactulose hydrogen breath testing

Subjects will undergo glucose and lactulose hydrogen breath tests for Small Intestinal Bacterial Overgrowth (SIBO) on consecutive days using a commercially available home base kits (Glucose Hydrogen Breath Test Collection Kit and Lactulose Hydrogen Breath Test Collection Kit for SIBO from Commonwealth Diagnostic International) prior to Rifaximin treatment and at week 13 of the study.

Intervention Type: DEVICE

Other Intervention Names

Xifaxan

Eligibility Criteria

Inclusion Criteria

• IBS-D (Rome IV Diagnostic Criteria)
• Diary compliance for at least 5 days and no rescue medications during baseline
• Appropriate levels of abdominal pain and diarrhea

Exclusion Criteria

• Pregnant women or planning on becoming pregnant while in the study, or lactating women while in the study
• Inflammatory bowel disease, diabetes mellitus, systemic sclerosis, or celiac disease
• Active gastrointestinal or hematological malignancy which requires ongoing treatment
• Surgery to the GI tract in the past 3 months
• Gastrointestinal infection or diverticulitis in the past 3 months
• Severe hepatic impairment
• Any use of antibiotics in the past month
• Current use of probiotics
• Any history of allergies to rifaximin or its derivatives
• Any comitant use of P-glycoprotein inhibitors (for example. Cyclosporine)
• Known allergies to glucose or lactulose

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Commonwealth Diagnostics International, Inc.

UNKNOWN

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

William Chey

Professor of Internal Medicine, Medical School and Professor of Nutritional Sciences, School of Public Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Chey, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00142925

Identifier Type: -

Identifier Source: org_study_id