CompletedPhase 4

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

United States148 participantsStarted 2020-01-09

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of treatment responders

Timeframe: first 4 weeks after rifaximin treatment

Trial details

NCT IDNCT03729271

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-01

View on ClinicalTrials.gov More Irritable Bowel Syndrome trials