A Phase 2 interventional study of Famotidine and Levocetirizine in Functional Gastrointestinal Disorders, sponsored by Buddhist Tzu Chi General Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Buddhist Tzu Chi General Hospital · Phase 2, Interventional, and Treatment
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.
628 studies on the registry are indexed under Gastrointestinal Diseases; 128 are open to participants now.
This study's planned enrollment of 45 is below the median of 77 across 422 interventional studies indexed under Gastrointestinal Diseases.
Browse Gastrointestinal Diseases studies →Buddhist Tzu Chi General Hospital is the lead sponsor of 84 studies on the registry; 21 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Famotidine 20mg/tab This product is used for the treatment of peptic ulcers and gastroesophageal reflux disease (GERD). It competitively inhibits histamine at the H2 receptors on gastric parietal cells, thereby reducing gastric acid secretion (Ministry of Health and Welfare Drug License No. 041352). Levocetirizine 5mg/tab This is an antihistamine used to relieve various symptoms of allergies. Levocetirizine is an antihistamine that selectively competes with histamine at the H1 receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory system (Ministry of Health and Welfare Drug License No. 023792).
Levocetirizine 5mg/tab This is an antihistamine used to relieve various symptoms of allergies. Levocetirizine is an antihistamine that selectively competes with histamine at the H1 receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory system (Ministry of Health and Welfare Drug License No. 023792). "Fuyuan" Gasmin Tablets 40mg/tab This product appears as a round, white tablet. It works in the gastrointestinal tract by reducing the surface tension of gas bubbles, causing the bubbles attached to the gastrointestinal mucosa to rupture due to the change in tension. This facilitates the expulsion of gas from the body through belching or flatulence. (Taiwan FDA Drug License No. 000415).
"Fuyuan" Gasmin Tablets 40mg/tab This product appears as a round, white tablet. It works in the gastrointestinal tract by reducing the surface tension of gas bubbles, causing the bubbles attached to the gastrointestinal mucosa to rupture due to the change in tension. This facilitates the expulsion of gas from the body through belching or flatulence. (Taiwan FDA Drug License No. 000415).
Drug: Fuyuan Gasmin
20mg twice daily
5mg once before bed
40mg/tab once before bed
40mg/tab twice daily
Change from Baseline on the Functional Dyspepsia Scale(FD) at 84 days
Possible scores range from 0 (Very slightly) to 6 (Very serious) 0=Very slightly 1=Slight 2=A little slightly 3=About medium 4=A bit serious 5=Severe 6=Very serious Change = (day 84 Score - Baseline Score).
Time frame: Baseline and day 84
Change from Baseline in Pain on the Gastrointestinal symptom rating scale (GSRS) at 84 days
Possible scores range from 1 (No pain) to 7 (very serious) 1=No pain 2=Very minor 3=Mild 4=Moderate 5=Moderate to severe 6= severe 7=very serious Change = (day 84 Score - Baseline Score).
Time frame: Baseline and day 84
Change from Baseline on the Pittsburgh sleep quality index (PSQI) at 84 days
Possible scores range from 0 (Never) to 3 (Occurs three times a week times or more) 0=Never 1=Less than once a week 2=Occurs once or twice a week 3=Occurs three times a week times or more Change = (day 84 Score - Baseline Score).
Time frame: Baseline and day 84
Change from Baseline on the Taiwanese Depression Scale (TDQ) at 84 days
Possible scores range from 0 (Never) to 3 (Always) 0=Never 1=Sometimes 2=Often 3=Always Change = (day 84 Score - Baseline Score).
Time frame: Baseline and day 84
Change from Baseline on the State-Trait Anxiety Inventory (STAI) at 84 days
Possible scores range from 1 (Never) to 4 (Always) 1=Never 2=Sometimes 3=Often 4=Always Change = (day 84 Score - Baseline Score).
Time frame: Baseline and day 84
Change from Baseline on the Perceived Stress Scale(PSS-10) at 84 days
Possible scores range from 0 (Never) to 4 (Always) 0=Never 1=Rarely 2=Sometimes 3=Often 4=Always Change = (day 84 Score - Baseline Score).
Time frame: Baseline and day 84
Change from Baseline on the Visceral Sensitivity Index (VSI) at 84 days
Possible scores range from 0 (Strongly disagree) to 5 (Strongly agree) 0=Strongly agree 1=Moderately agree 2=Mildly agree 3=Mildly disagree 4 =Moderately disagree 5=Strongly disagree Change = (day 84 Score - Baseline Score).
Time frame: Baseline and day 84
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Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Buddhist Tzu Chi General Hospital