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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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.

Ming-Wun Wong contact

+886 8561825 ext. 13224

hypertr42@gmail.com

Taiwan1 site, 1 recruiting

  • Hualien Tzu Chi Hospital

    Hualien City

    Ming-Wun Wong, +886 8561825 ext. 13224, hypertr42@gmail.com

    Recruiting

Other trials in Taiwan

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.

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 groups in NCT07857941
Study groupRoleWhat they receive
H1/H2 combination antagonist groupExperimentalFamotidine 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 groupExperimentalLevocetirizine 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 groupPlacebo 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  1. First posted5 Oct 2026
  2. Study start1 Jan 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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)
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 33493503

  • Drossman 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 27147121

  • Wong 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 36693025

  • Drossman 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 29274869

  • Talley 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 17686660

  • Vanheel 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 23474421

  • Cirillo 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 26077177

  • Moayyedi 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 28631728

  • Matter 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 2226097

  • Purssell 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 35069992

  • Scalera 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 24023483

  • Singh 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 24851523

  • Purssell 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 37253969

  • Leung 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 27273168

  • Bajaj 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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ming-Wun Wong (+886 8561825 ext. 13224, hypertr42@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline on the Functional Dyspepsia Scale(FD) at 84 days (time frame: Baseline and day 84). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07857941, which also lists 71 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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