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WITHDRAWN
NCT04612803
PHASE3

Antihistamines in the Treatment of Irritable Bowel Syndrome With Diarrhea

Sponsor: University of Cincinnati

View on ClinicalTrials.gov

Summary

Irritable bowel syndrome is a functional disorder of the gastrointestinal tract diagnosed with the Rome criteria. The Rome IV criteria are based on abdominal pain symptoms and stool habits including stool frequency and stool forms \[1\]. They define 3 main subtypes based on symptoms: 1) IBS with diarrhea; 2) IBS with constipation: and 3) mixed symptoms of constipation and diarrhea. The IBS with diarrhea (IBS-D) subtype has the highest prevalence. Currently, treatment of IBS-D includes antidiarrheals, bile acid sequestrants, antispasmodics, tricyclic antidepressants, and FODMAP diet. However, many patients are intolerant or unresponsive to the above treatments. Outside of IBS, chronic diarrhea affects about 5% of adults. We have described a syndrome in a subset of IBS patients presenting with post prandial diarrhea, flushing and dermatographia whose symptoms are prevented by pre-treatment with combined H1 and H2 antihistamines \[2\]. However, the prevalence of this syndrome among the IBS + D patients is not known nor have the clinical characteristics or predictors of antihistamine responsive IBS + D been defined.

Official title: Antihistamines in the Treatment of Irritable Bowel Syndrome With Diarrhea: a Cross-Over Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

0

Start Date

2020-02-01

Completion Date

2026-08-31

Last Updated

2026-09-04

Healthy Volunteers

No

Interventions

DRUG

Antihistamine

Cetirizine 10 mg and famotidine 20 mg will be dispensed to each patient, to be taken twice a day at 6-9AM one hour before eating breakfast and again at evening 12 hours after the morning dose for 30 days

DRUG

Placebo

These medications will be pre-packaged by the UC Health pharmacy in a manner that results in a double-blinded cross-over design.

Locations (1)

UC Health

Cincinnati, Ohio, United States