Testing combined H1 and H2 antihistamines for functional dyspepsia
Official title: Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction: Impact on Gastrointestinal and Psychological Symptoms as Well as Pathophysiological Alterations
Run by Buddhist Tzu Chi General Hospital · NCT07857941 · Data updated 2026-11-12
We’re testing whether a combination of an H1 antihistamine and an H2 antihistamine helps people with functional dyspepsia more than a single antihistamine.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Buddhist Tzu Chi General Hospital Academic / other |
| Locations | 1 site (Hualien City) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT07857941 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18-64 with clinically defined functional dyspepsia and no recent upper GI surgery or active infections.
✕Probably not a fit
Patients whose symptoms are driven by non-histamine pathways or who have contraindications to antihistamines may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 interventional trial investigates how a combined H1 and H2 antihistamine regimen affects symptoms in adults with functional dyspepsia. The study compares a dual-antihistamine approach to looking at histamine pathways thought to drive inflammation and permeability in the gut. Researchers will administer famotidine (an H2 blocker) and levocetirizine (an H1 blocker) to eligible participants and monitor changes in upper GI symptoms and related biomarkers. The trial design reflects a neutral, medical-journal tone, focusing on symptom outcomes and safety signals. Results could clarify whether dual antihistamine therapy offers a broader benefit than single-agent therapy in FD.”,
Why it matters
Potential benefit: If successful, the approach could provide improved symptom control for FD and inform treatment strategies targeting gut-immune interactions.
How similar studies have gone: Previous analyses suggest antihistamines have beneficial effects in FD; this study explores whether combining H1 and H2 blockers yields added benefit.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Hualien Tzu Chi Hospital
Hualien City, Taiwan Recruiting
Study contacts
- Study coordinator: Ming-Wun Wong
- Email: hypertr42@gmail.com
- Phone: +886 8561825
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.