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Could allergy pills calm irritable bowel syndrome?

NCT ID NCT04612803

Disease control Sponsor: University of Cincinnati 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 Results may not be published yet.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
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests whether a combination of two common antihistamines, cetirizine and famotidine, can reduce symptoms in people with diarrhea-predominant irritable bowel syndrome (IBS-D). Participants take the antihistamines or a placebo for 30 days, then switch, so each person serves as their own comparison. The study focuses on people with moderate to severe symptoms who have not improved with standard treatments. Researchers measure changes in symptom severity and quality of life to see if antihistamines offer relief.

What this could mean

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

Active substance
A combination of two antihistamines: cetirizine (Zyrtec) and famotidine (Pepcid), taken twice daily for 30 days.
What this could lead to
If effective, this could offer a new treatment option for people with diarrhea-predominant IBS who have not responded to standard therapies.
What could go wrong
This is an early-phase trial with a small number of participants. The antihistamines may not relieve symptoms for everyone, and side effects are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Started

Feb 2020

Finished

Aug 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 years and older

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: * Age 18 years and older * Prior to Diagnosis of IBS + diarrhea based on ICD 10 codes with or without constipation unresponsive to prior treatments * Moderate to severe symptom severity score (\>175 points) based on IBS symptom severity scale * Seeking evaluation by a health care professional * Negative serologic celiac panel * No response to lactose elimination diet by history * Normal colonoscopy * Able to complete symptoms diaries and global evaluations Exclusion Criteria: * Confirmed IgE dependent food allergy as a cause of the gastrointestinal symptoms. * Lactose intolerance by history * Celiac disease by serology * Inflammatory bowel disease or colitis * Bile acid diarrhea by history * Post-surgical GI symptoms (e.g., dumping syndrome) by history * No colonoscopy performed * GI malabsorption * Current pregnancy * Current severe depression or history of psychosis * Current treatment with tricyclic antidepressants

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Conditions

The condition(s) this trial relates to.

familial dermatographia irritable bowel syndrome

As listed by the trial registrant

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

Dermatographism Irritable bowel syndrome Post-prandial diarrhea

Contacts and locations

Locations

  • UC Health

    Cincinnati, Ohio, 45219, United States

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