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

NCT03729271 | Completed Phase 4 FDA Drug FDA Device

• 1 other identifier: HUM00142925
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea

Keywords

IBS; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of treatment responders

  A responder is defined as a patient simultaneously meeting weekly response criteria for abdominal pain (≥30% decrease from baseline in mean weekly pain score) and stool consistency (≥50% decrease from baseline in number of days/week with Bristol Stool Scale type 6 or 7 stool) during ≥2 of the 4 weeks after treatment

  first 4 weeks after rifaximin treatment

Secondary Outcomes (7)

• Severity of abdominal pain by numeric rating scale (0-10)

  baseline (week 1), up to 12 weeks

• Stool consistency by Bristol Stool Form Scale (1-7)

  baseline (week 1), up to 12 weeks

• Severity of bloating by numeric rating scale (0-10)

  baseline (week 1), up to 12 weeks

• Severity of bowel urgency by rating scale (0-10)

  baseline (week 1), up to 12 weeks

• Compare the predictive value of a pre-treatment glucose vs. lactulose hydrogen breath test for symptomatic response to rifaximin in IBS-D patients.

  baseline (week 1), up to 12 weeks

Study Arms (1)

Rifaximin and breath tests

EXPERIMENTAL

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.

Drug: Rifaximin; Device: Glucose and lactulose hydrogen breath testing

Interventions

Rifaximin DRUG

Rifaximin will be given during weeks 2-4

Also known as: Xifaxan

Rifaximin and breath tests

Glucose and lactulose hydrogen breath testing 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.

Rifaximin and breath tests

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Commonwealth Diagnostics International, Inc.: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• William Chey, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: The study drug will be open label. However, the order of the breath tests that are performed (glucose and lactulose) will be blinded to the participant and the person performing the breath sample, and the results of the breath test.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine, Medical School and Professor of Nutritional Sciences, School of Public Health

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: November 2, 2018
• Study Start: January 9, 2020
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-02

Locations

US (1)