Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBuddhist Tzu Chi General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Famotidine
Drug20mg twice daily
Levocetirizine
Drug5mg once before bed
Fuyuan Gasmin
Drug40mg/tab once before bed
Fuyuan Gasmin
Drug40mg/tab twice daily
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: H1/H2 combination antagonist groupExperimental treatment 0 interventions
Group B: H1 antagonist only groupExperimental treatment 0 interventions
Group C: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
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).
Time frame
Baseline and day 842
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 843
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 844
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 84Sponsors and contacts
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Source ClinicalTrials.gov