Rifaximin + Hydrogen Breath Test for IBS-D

Palo Alto (17 mi)

Overseen byWilliam Chey, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Michigan

No Placebo Group

Prior Safety Data

Approved in 6 jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals with Irritable Bowel Syndrome predominant diarrhea (IBS-D) who meet specific criteria of abdominal pain and diarrhea, have kept a symptom diary for at least 5 days without rescue meds, and fit the Rome IV Diagnostic Criteria. It's not open to those with certain other diseases like inflammatory bowel disease or diabetes, recent GI surgery patients, severe liver issues, pregnant or lactating women, anyone who has taken antibiotics recently or uses probiotics.

Inclusion Criteria

I kept a health diary for 5 days without needing emergency meds.

Exclusion Criteria

I am not taking any medications like Cyclosporine.

I have severe liver problems.

I have taken antibiotics in the last month.

I am currently taking probiotics.

I am currently being treated for cancer in my digestive system or blood.

I have not had GI tract surgery in the last 3 months.

Treatment Details

The study tests if hydrogen breath testing can predict how well people with IBS-D respond to rifaximin treatment. Participants will take rifaximin and undergo glucose and lactulose hydrogen breath tests while providing biological samples and completing online surveys about their symptoms.

1Treatment groups

Experimental Treatment

Group I: Rifaximin and breath testsExperimental Treatment2 Interventions

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.

Rifaximin is already approved in United States, Canada, European Union, India for the following indications:

🇺🇸 Approved in United States as Xifaxan for: