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Breath test may guide IBS-D treatment choices

NCT ID NCT03729271

Knowledge-focused Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether a simple breath test can help predict which people with diarrhea-predominant irritable bowel syndrome (IBS-D) will respond to the drug rifaximin. 148 participants took rifaximin and completed breath tests and surveys. The goal was to see if the breath test could identify those most likely to get relief from abdominal pain and diarrhea.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rifaximin (Xifaxan)
What this could lead to
If successful, this could help doctors identify which IBS-D patients are most likely to benefit from rifaximin, making treatment more personalized.
What could go wrong
This is a completed Phase 4 study focused on prediction, not a new treatment. The breath test may not reliably predict response, and results may not apply to all IBS-D patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

148 people

The number who actually took part.

Started

Jan 2020

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

irritable bowel syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Irritable bowel syndrome Irritable bowel syndrome with diarrhea

Contacts and locations

Locations

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.