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RECRUITING
NCT07857941
PHASE2

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

Sponsor: Buddhist Tzu Chi General Hospital

View on ClinicalTrials.gov

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.

Official title: Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction: Impact on Gastrointestinal and Psychological Symptoms as Well as Pathophysiological Alterations

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2025-01-01

Completion Date

2026-12-31

Last Updated

2026-10-05

Healthy Volunteers

No

Interventions

DRUG

Famotidine

20mg twice daily

DRUG

Levocetirizine

5mg once before bed

DRUG

Fuyuan Gasmin

40mg/tab once before bed

DRUG

Fuyuan Gasmin

40mg/tab twice daily

Locations (1)

Hualien Tzu Chi Hospital

Hualien City, Taiwan