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

Completed · Phase 4

Conditions studied: Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea

In brief

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.

Key facts

Study ID

NCT03729271

Run by

University of Michigan

People needed

148

Starts

2020-01-09

Expected to finish

2026-01-01

Last updated by the study team

2026-01-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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