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Antibiotic

Rifaximin + Hydrogen Breath Test for IBS-D

Phase 4

Recruiting

Led By William Chey, M.D.

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diary compliance for at least 5 days and no rescue medications during baseline

Be older than 18 years old

Must not have

Any concomitant use of P-glycoprotein inhibitors (for example, Cyclosporine)

Severe hepatic impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 1), up to 12 weeks

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new treatment for IBS-D, which includes online surveys, rifaximin, and hydrogen breath testing.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Rifaximin may cause side effects such as digestive disturbances (nausea, bloating), headaches, dizziness, increased risk of infection due to gut flora changes. The hydrogen breath test is generally safe but might cause some discomfort like bloating or cramping.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any medications like Cyclosporine.

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I have severe liver problems.

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I have taken antibiotics in the last month.

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I am currently taking probiotics.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 1), up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 1), up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 1), up to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of treatment responders

Secondary study objectives

Compare the predictive value of a pre-treatment glucose or lactulose hydrogen breath test

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

Irritable Bowel Syndrome - Quality of Life Measure responder

+4 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rifaximin

2005

Completed Phase 4

~3120

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,863 Previous Clinical Trials

6,441,471 Total Patients Enrolled

13 Trials studying Irritable Bowel Syndrome

863 Patients Enrolled for Irritable Bowel Syndrome

Commonwealth Diagnostics International, Inc.UNKNOWN

William Chey, M.D.Principal Investigator - University of Michigan

University of Michigan C.S. Mott Children's Hospital, University of Michigan Health System, University of Michigan Hospital, Von Voigtlander Women's Hospital

Emory University School Of Medicine (Medical School)

University Of Mi Hosps (Residency)