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Bloating relief? tiny trial tests antibiotic for stomach paralysis

NCT ID NCT04254549

Symptom relief Sponsor: Mayo Clinic 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 small Phase 2 trial tested whether the antibiotic rifaximin could reduce bloating in people with diabetic gastroparesis, a condition where the stomach empties slowly. Only 5 participants were enrolled before the study was terminated early. The main goal was to measure changes in bloating using detailed questionnaires.

What this could mean

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

Active substance
rifaximin
What this could lead to
If it works, this could point toward a treatment for bloating in diabetic gastroparesis.
What could go wrong
This trial was terminated early and enrolled only 5 people, so results are very limited. It may not show clear benefit or apply to larger groups.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

5 people

The number who actually took part.

Started

Jun 2019

Finished

Apr 2025

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 75 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 * Men and women adult patients, aged 18-75, with diabetic gastroparesis * Diagnosis of diabetic gastroparesis will have been made previously using a combination of symptoms (e.g., nausea, vomiting, bloating, early satiety, abdominal pain), the absence of mechanical obstruction, and delayed gastric emptying using a 4-hour, solid phase scintigraphic study (GES; \> 20% remaining at 4 hours) Exclusion Criteria * Prior surgery to the stomach or esophagus * Known mechanical obstruction of the GI tract * Current or recent (\< 4 weeks) use of opioids * Current/active use of cannabis * Current or recent (\< 4 weeks) use of antibiotics * Current or recent use of antifungal agents (\< 4 weeks) * Prior treatment with rifaximin (\< 1 year) * Uncontrolled diabetes with a HgbA1c \> 12 * Severe uncontrolled or untreated anxiety or depression.

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Conditions

The condition(s) this trial relates to.

Crohn disease gastroparesis

As listed by the trial registrant

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

Crohn disease Diabetic gastroparesis

Contacts and locations

Locations

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224, United States

More trials for these conditions

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