Meu-cinn to improve the stomach lining in adults with functional dyspepsia

Effects of Meu-cinn on Promoting Gastric Mucosal Health in Adults With Functional Dyspepsia: A Randomized, Double-blind, Placebo-controlled Clinical Trial

This tests whether taking Meu-cinn daily helps improve gastric mucosal health and records any side effects in adults with functional dyspepsia.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 19 Years to 70 Years
• Sex: All
• Sponsor: Pusan National University Yangsan Hospital (other)
• Locations: 1 site (Yangsan)
• Trial ID: NCT06630455 on ClinicalTrials.gov

What this trial studies

Adults meeting Rome IV criteria for functional dyspepsia are assigned to take either Meu-cinn or a matching placebo once daily for eight weeks, with clinic visits at weeks 1, 2, 4, and 8 for examinations and tests. The trial compares gastric mucosal health measures between the Meu-cinn and placebo groups and tracks adverse events throughout treatment. Key exclusions include recent H. pylori eradication, recent use of NSAIDs/steroids/antibiotics/aspirin/antithrombotics/acid suppressants, significant prior upper GI surgery or procedures, active or recent peptic ulcers, reflux esophagitis LA grade A or higher, malignant tumors on recent endoscopy, and uncontrolled hypertension. The primary focus is on changes in gastric mucosal health and the safety/tolerability profile of Meu-cinn over the 8-week treatment period.

Who should consider this trial

Good fit: Adults diagnosed with functional dyspepsia by Rome IV criteria who are not taking excluded medications, have no recent significant upper GI disease or surgery, and can attend scheduled in-person visits at the trial site are the intended participants.

Not a fit: Patients with active or recent peptic ulcer disease, recent H. pylori treatment, recent use of excluded drugs, significant prior upper GI surgery, uncontrolled hypertension, or other listed exclusion conditions are unlikely to be eligible or to benefit from this intervention.

Why it matters

Potential benefit: If effective, Meu-cinn could improve gastric mucosal health and potentially lessen dyspeptic symptoms while being tolerated safely by patients.

How similar studies have performed: Similar placebo-controlled trials of agents designed to improve gastric mucosal health in functional dyspepsia have shown mixed results, so this specific approach is not yet proven.

Eligibility criteria

Inclusion Criteria:

* Rome IV-based functional dyspepsia-

Exclusion Criteria:

* Patients with gastrointestinal symptoms requiring immediate drug treatment.
* Individuals with a history of hypersecretory gastric disorders like Zollinger-Ellison syndrome.
* Individuals who received Helicobacter pylori eradication therapy within 4 weeks prior to the trial.
* Individuals who have taken nonsteroidal anti-inflammatory drugs, steroids, antibiotics, aspirin, antithrombotic agents, or acid suppressants within the last month.
* Individuals with a history of upper gastrointestinal surgery, stricture, bleeding, or procedures like esophageal dilation or mucosal resection within the last year.
* Individuals with gastric ulcers (active or healing), duodenal ulcers (active or healing), reflux esophagitis (LA grade A or higher), or malignant tumors identified within the last 6 months through endoscopy.
* Patients with uncontrolled hypertension (resting BP ≥160/100 mmHg).
* Patients with uncontrolled diabetes (fasting glucose ≥160 mg/dL).
* Individuals with creatinine levels ≥ 2 times the upper limit of normal at the research institution.
* Individuals with aspartate aminotransferase or alanine aminotransferase levels ≥ 2 times the upper limit of normal at the research institution.
* Alcohol abusers.
* Individuals taking medications for psychiatric disorders (except those taking intermittent medication for sleep disorders).
* Pregnant or breastfeeding women or those planning to become pregnant during the clinical trial period.
* Individuals with allergies to any components of the study foods.
* Individuals who participated in or plan to participate in another drug clinical trial within the last month.
* Individuals deemed unsuitable for the study by the investigator for other reasons.

Where this trial is running

Yangsan

• Pusan National University Yangsan Hospital — Yangsan, South Korea (RECRUITING)

Study contacts

• Principal investigator: Sang Yeoup Lee, Professor, MD, PhD — Pusan National University Yangsan Hospital
• Study coordinator: Sang Yeoup Lee, Professor, MD, PhD

Conditions: Functioanl Dyspepsia