drugset / Trial / NCT04612803

Antihistamines in the Treatment of Irritable Bowel Syndrome With Diarrhea

NCT04612803 ↗

Phase 3 Withdrawn University of Cincinnati
RandomizedCrossoverTriple-blindTreatment

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.

Timeline

Start
2020-02-01
Primary completion
2026-08-31
Completion
2026-08-31

Outcome

Outcome not reported

Stopped (Business): “no funding for clinical research space”

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cetirizine Other / unclassified 10 mg —
Comparator Famotidine Other / unclassified 20 mg —