drugset / Trial / NCT07857941

Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2

NCT07857941 ↗

Phase 2 Recruiting 45 enrolled Buddhist Tzu Chi General Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Functional dyspepsia (FD) is associated with inflammatory responses caused by the release of histamine from eosinophils and mast cells, leading to increased intestinal mucosal permeability, which is a key pathogenic mechanism. Meta-analyses have shown that H2 antihistamine drugs are as effective as proton pump inhibitors in treating FD, while H1 antihistamines achieve an efficacy rate of up to 79%. However, there is no research comparing the effects and pathological changes of combined H1/H2 antagonists versus single H1 antagonists in the treatment of functional dyspepsia. Recent studies have shown that fatty liver disease and irritable bowel syndrome (IBS) share common comorbid factors, including obesity, gut microbiota, dietary factors, and immune-mediated causes. This has raised interest in whether these two conditions co-exist in patient populations. Moreover, the prevalence of IBS is higher in patients with fatty liver disease compared to global prevalence rates. A recent study found that up to 55.6% of patients with fatty liver have IBS, and it further suggests that patients with both IBS and fatty liver experience a lower quality of life and more severe physical and psychological symptoms.

Timeline

Start
2025-01-01
Primary completion
2026-12-31
Completion
2026-12-31

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Famotidine Other / unclassified 20 mg —
Comparator Gasmin Unknown 40 mg —
Subject Levocetirizine Unknown 5 mg —

Indications

No indication recorded.