Functional Gastrointestinal DisordersPhase 2NCT07857941
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
A Phase 2 study testing Famotidine, Levocetirizine and Fuyuan Gasmin in people with Functional Gastrointestinal Disorders, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Functional Gastrointestinal Disorders
- What is being tested?
- Famotidine, Levocetirizine and Fuyuan Gasmin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Hualien Tzu Chi Hospital
Hualien City
Ming-Wun Wong, +886 8561825 ext. 13224, hypertr42@gmail.com
About this study
Official title: Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction: Impact on Gastrointestinal and Psychological Symptoms as Well as Pathophysiological Alterations
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.
- Conditions
- Functional Gastrointestinal Disorders
- Being tested
- Famotidine, Levocetirizine, Fuyuan Gasmin
- Keywords
- antihistamine, Gut-brain axis dysregulation, gut-liver-brain axis, dyspepsia
- Medical subject headings
- Gastrointestinal Diseases, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamotidineDrug
20mg twice daily
LevocetirizineDrug
5mg once before bed
Fuyuan GasminDrug
40mg/tab once before bed
Fuyuan GasminDrug
40mg/tab twice daily
| Study group | Role | What they receive |
|---|---|---|
| H1/H2 combination antagonist group | Experimental | 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). |
| H1 antagonist only group | Experimental | 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). |
| Control group | Placebo comparator | "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). Receives: Drug: Fuyuan Gasmin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline and day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (71)Papers the sponsor has linked to this study.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857941
- Sponsor's protocol ID
- TCRD114-021
- Status last verified
- Jan 2026
- First submitted
- 21 Feb 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Margolis KG, Cryan JF, Mayer EA. The Microbiota-Gut-Brain Axis: From Motility to Mood. Gastroenterology. 2021 Apr;160(5):1486-1501. doi: 10.1053/j.gastro.2020.10.066. Epub 2021 Jan 22.
PubMed 33493503Drossman DA, Hasler WL. Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction. Gastroenterology. 2016 May;150(6):1257-61. doi: 10.1053/j.gastro.2016.03.035. No abstract available.
PubMed 27147121Wong MW, Hsiao SH, Wang JH, Yi CH, Liu TT, Lei WY, Hung JS, Liang SW, Lin L, Gyawali CP, Chen PR, Chen CL. Esophageal Hypervigilance and Visceral Anxiety Contribute to Symptom Severity of Laryngopharyngeal Reflux. Am J Gastroenterol. 2023 May 1;118(5):786-793. doi: 10.14309/ajg.0000000000002151. Epub 2022 Dec 14.
PubMed 36693025Drossman DA, Tack J, Ford AC, Szigethy E, Tornblom H, Van Oudenhove L. Neuromodulators for Functional Gastrointestinal Disorders (Disorders of Gut-Brain Interaction): A Rome Foundation Working Team Report. Gastroenterology. 2018 Mar;154(4):1140-1171.e1. doi: 10.1053/j.gastro.2017.11.279. Epub 2017 Dec 22.
PubMed 29274869Talley NJ, Walker MM, Aro P, Ronkainen J, Storskrubb T, Hindley LA, Harmsen WS, Zinsmeister AR, Agreus L. Non-ulcer dyspepsia and duodenal eosinophilia: an adult endoscopic population-based case-control study. Clin Gastroenterol Hepatol. 2007 Oct;5(10):1175-83. doi: 10.1016/j.cgh.2007.05.015. Epub 2007 Aug 7.
PubMed 17686660Vanheel H, Vicario M, Vanuytsel T, Van Oudenhove L, Martinez C, Keita AV, Pardon N, Santos J, Soderholm JD, Tack J, Farre R. Impaired duodenal mucosal integrity and low-grade inflammation in functional dyspepsia. Gut. 2014 Feb;63(2):262-71. doi: 10.1136/gutjnl-2012-303857. Epub 2013 Mar 8.
PubMed 23474421Cirillo C, Bessissow T, Desmet AS, Vanheel H, Tack J, Vanden Berghe P. Evidence for neuronal and structural changes in submucous ganglia of patients with functional dyspepsia. Am J Gastroenterol. 2015 Aug;110(8):1205-15. doi: 10.1038/ajg.2015.158. Epub 2015 Jun 16.
PubMed 26077177Moayyedi P, Lacy BE, Andrews CN, Enns RA, Howden CW, Vakil N. ACG and CAG Clinical Guideline: Management of Dyspepsia. Am J Gastroenterol. 2017 Jul;112(7):988-1013. doi: 10.1038/ajg.2017.154. Epub 2017 Jun 20.
PubMed 28631728Matter SE, Bhatia PS, Miner PB Jr. Evaluation of antral mast cells in nonulcer dyspepsia. Dig Dis Sci. 1990 Nov;35(11):1358-63. doi: 10.1007/BF01536741.
PubMed 2226097Purssell H, Whorwell PJ, Athwal VS, Vasant DH. Non-alcoholic fatty liver disease in irritable bowel syndrome: More than a coincidence? World J Hepatol. 2021 Dec 27;13(12):1816-1827. doi: 10.4254/wjh.v13.i12.1816.
PubMed 35069992Scalera A, Di Minno MN, Tarantino G. What does irritable bowel syndrome share with non-alcoholic fatty liver disease? World J Gastroenterol. 2013 Sep 7;19(33):5402-20. doi: 10.3748/wjg.v19.i33.5402.
PubMed 24023483Singh SP, Kar SK, Panigrahi MK, Misra B, Pattnaik K, Bhuyan P, Meher C, Agrawal O, Rout N, Swain M. Profile of patients with incidentally detected nonalcoholic fatty liver disease (IDNAFLD) in coastal eastern India. Trop Gastroenterol. 2013 Jul-Sep;34(3):144-52. doi: 10.7869/tg.118.
PubMed 24851523Purssell H, Bennett L, Street O, Hanley KP, Hanley N, Vasant DH, Athwal VS. The prevalence and burden of Rome IV bowel disorders of gut brain interaction in patients with non-alcoholic fatty liver disease: a cross-sectional study. Sci Rep. 2023 May 30;13(1):8769. doi: 10.1038/s41598-023-35774-5.
PubMed 37253969Leung C, Rivera L, Furness JB, Angus PW. The role of the gut microbiota in NAFLD. Nat Rev Gastroenterol Hepatol. 2016 Jul;13(7):412-25. doi: 10.1038/nrgastro.2016.85. Epub 2016 Jun 8.
PubMed 27273168Bajaj JS. Alcohol, liver disease and the gut microbiota. Nat Rev Gastroenterol Hepatol. 2019 Apr;16(4):235-246. doi: 10.1038/s41575-018-0099-1.
PubMed 30643227