Meu-cinn for Gastric Mucosal Health in Adults With Functional Dyspepsia
- Conditions
- Functioanl Dyspepsia
- Interventions
- Dietary Supplement: Meu-cinnDietary Supplement: Placebo
- Registration Number
- NCT06630455
- Lead Sponsor
- Pusan National University Yangsan Hospital
- Brief Summary
This clinical trial aims to determine whether Meu-cinn promotes gastric mucosal health in adults with functional dyspepsia and to assess its safety.
The main questions are:
* Does Meu-cinn promote gastric mucosal health in participants?
* What side effects occur when participants take Meu-cinn?
- Detailed Description
Researchers will compare Meu-cinn to placebo to evaluate their effectiveness in promoting gastric mucosal health.
Participants will:
* Take Meu-cinn or a placebo daily for 8 weeks.
* Visit the clinic at 1, 2, 4, and 8 weeks for checkups and tests.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Rome IV-based functional dyspepsia-
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Meu-cinn group Meu-cinn This group takes Meu-cinn for 8 weeks. Placebo group Placebo This group takes placebo for 8 weeks.
- Primary Outcome Measures
Name Time Method The Korean version of the Gastrointestinal Symptom Rating Scale, Total score From enrollment to the end of treatment at 8 weeks Measured at baseline and 8 weeks. This is a 4-point Likert scale for each of the 15 items, with scores ranging from 0 to 3. A score of 0 indicates no symptoms, and 3 represents very severe symptoms. The higher the overall score, the more severe the gastrointestinal symptoms. The minimum value was 0, and the maximum value was 45, and higher scores mean a worse outcome.
- Secondary Outcome Measures
Name Time Method Pepsinogen I/Pepsinogen II ratio From enrollment to the end of treatment at 8 weeks Measured at baseline and 8 weeks
Visual Analogue Scale for evaluating gastric mucosal improvement From enrollment to the end of treatment at 8 weeks Measured at baseline and 8 weeks. The minimum value was 0 and the maximum value was 100, and higher scores mean a worse outcome.
Gastrin-17 level (ng/L) From enrollment to the end of treatment at 8 weeks Measured at baseline and 8 weeks
Gastrointestinal symptom score From enrollment to the end of treatment at 8 weeks Measured at baseline and 8 weeks. The minimum value was 0 and the maximum value was 40, and higher scores mean a worse outcome. For each gastrointestinal symptom, the minimum value was 0, and the maximum value was 4, and higher scores mean a worse outcome.
Pepsinogen I level (ng/mL) From enrollment to the end of treatment at 8 weeks Measured at baseline and 8 weeks
The Korean version of the Gastrointestinal Symptom Rating Scale, Subtotal score of upper abdomen From enrollment to the end of treatment at 8 weeks Measure at baseline, 1, 2, 4, and 8 weeks. This is a 4-point Likert scale for each of the 8 items, with scores ranging from 0 to 3. A score of 0 indicates no symptoms, and 3 represents very severe symptoms. The higher the overall score, the more severe the gastrointestinal symptoms. The minimum value was 0, and the maximum value was 21, and higher scores mean a worse outcome.
Patient's global assessment score From enrollment to the end of treatment at 8 weeks The 5-point Likert scale for the Patient's Global Assessment Score is a self-reported tool where patients rate their disease activity. It uses an order scale, with 5 indicating "Very Good" and 1 indicating "Poor." The patient evaluates their condition based on this scale: Very Good-Good-Fair-Unchanged-Poor
Pepsinogen II level (ng/mL) From enrollment to the end of treatment at 8 weeks Measured at baseline and 8 weeks
High-sensitive C-reactive protein (mg/dL) From enrollment to the end of treatment at 8 weeks Measured at baseline and 8 weeks
Immunuglobulin G (mg/dL) From enrollment to the end of treatment at 8 weeks Measured at baseline and 8 weeks
Immunoglobulin A (mg/dL) From enrollment to the end of treatment at 8 weeks Measured at baseline and 8 weeks
Immunoglobulin M (mg/dL) From enrollment to the end of treatment at 8 weeks Measured at baseline and 8 weeks
The derivatives of reactive oxidative metabolites (CARR U) From enrollment to the end of treatment at 8 weeks Measured at baseline and 8 weeks
Biological antioxidant potential (u M) From enrollment to the end of treatment at 8 weeks Measured at baseline and 8 weeks
Trial Locations
- Locations (1)
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of