RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Buddhist Tzu Chi General Hospital • ClinicalTrials.gov ID: NCT07857941

Registry updated: 2026-10-05

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Description

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.

Interventions

Famotidine (Drug)
20mg twice daily
Levocetirizine (Drug)
5mg once before bed
Fuyuan Gasmin (Drug)
40mg/tab once before bed
Fuyuan Gasmin (Drug)
40mg/tab twice daily

Eligibility criteria

Inclusion Criteria: * Aged between 18-64 years, mentally alert, and willing to sign the informed consent form. * Meeting the definition of functional dyspepsia: Functional dyspepsia is characterized by chronic upper gastrointestinal symptoms (at least once a week, persisting for at least three months, with symptom onset at least six months prior), including any of the following: postprandial bloating, early satiety, epigastric pain, or epigastric burning, with no abnormalities detected on upper gastrointestinal endoscopy. Exclusion Criteria: * Have undergone upper gastrointestinal surgery in the past two months. * Are currently using antibiotics for an infectious disease. * Pregnant or breastfeeding women. * Have myocardial ischemia or have recently experienced a myocardial infarction. * Unable to cooperate.

Conditions

Functional Gastrointestinal Disorders

Locations

Hualien Tzu Chi Hospital — Hualien City, Taiwan

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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