Meu-cinn for Gastric Mucosal Health 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 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?

Study Overview

• Status: Recruiting
• Conditions: Functioanl Dyspepsia
• Intervention / Treatment: Dietary supplement: Meu-cinn; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sang Yeoup Lee, Professor, MD, PhD; Phone Number: 82+55-360-2860; Email: drsaylee@gmail.com

Study Locations

• Korea, Republic of
  • Yangsan, Korea, Republic of, 50612
    • Recruiting
    • Pusan National University Yangsan Hospital
    • Contact: Sang Yeoup Lee, Professor, MD, PhD; Phone Number: 82-55-360-2860; Email: drsaylee@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; This group takes placebo for 8 weeks.	Dietary supplement: Placebo; Placebo 250 mg/day for 8 weeks
Experimental: Meu-cinn group; This group takes Meu-cinn for 8 weeks.	Dietary supplement: Meu-cinn; Meu-cinn 250 mg/day for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Korean version of the Gastrointestinal Symptom Rating Scale, Total score	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.	From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Korean version of the Gastrointestinal Symptom Rating Scale, Subtotal score of upper abdomen	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.	From enrollment to the end of treatment at 8 weeks
Patient's global assessment score	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	From enrollment to the end of treatment at 8 weeks
Visual Analogue Scale for evaluating gastric mucosal improvement	Measured at baseline and 8 weeks. The minimum value was 0 and the maximum value was 100, and higher scores mean a worse outcome.	From enrollment to the end of treatment at 8 weeks
Gastrointestinal symptom score	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.	From enrollment to the end of treatment at 8 weeks
Pepsinogen I level (ng/mL)	Measured at baseline and 8 weeks	From enrollment to the end of treatment at 8 weeks
Pepsinogen II level (ng/mL)	Measured at baseline and 8 weeks	From enrollment to the end of treatment at 8 weeks
Pepsinogen I/Pepsinogen II ratio	Measured at baseline and 8 weeks	From enrollment to the end of treatment at 8 weeks
Gastrin-17 level (ng/L)	Measured at baseline and 8 weeks	From enrollment to the end of treatment at 8 weeks
High-sensitive C-reactive protein (mg/dL)	Measured at baseline and 8 weeks	From enrollment to the end of treatment at 8 weeks
Immunuglobulin G (mg/dL)	Measured at baseline and 8 weeks	From enrollment to the end of treatment at 8 weeks
Immunoglobulin A (mg/dL)	Measured at baseline and 8 weeks	From enrollment to the end of treatment at 8 weeks
Immunoglobulin M (mg/dL)	Measured at baseline and 8 weeks	From enrollment to the end of treatment at 8 weeks
The derivatives of reactive oxidative metabolites (CARR U)	Measured at baseline and 8 weeks	From enrollment to the end of treatment at 8 weeks
Biological antioxidant potential (u M)	Measured at baseline and 8 weeks	From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Investigators: Principal Investigator: Sang Yeoup Lee, Professor, MD, PhD, Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 4, 2024
• First Submitted That Met QC Criteria: October 4, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: June 1, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: 12-2024-009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No