Meu-cinn for Gastric Mucosal Health in Adults With Functional Dyspepsia

NCT06630455 | Recruiting

• 1 other identifier: 12-2024-009
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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?

Conditions

Functioanl Dyspepsia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• The Korean version of the Gastrointestinal Symptom Rating Scale, Subtotal score of upper abdomen

  From enrollment to the end of treatment at 8 weeks

• Patient's global assessment score

  From enrollment to the end of treatment at 8 weeks

• Visual Analogue Scale for evaluating gastric mucosal improvement

  From enrollment to the end of treatment at 8 weeks

• Gastrointestinal symptom score

  From enrollment to the end of treatment at 8 weeks

• Pepsinogen I level (ng/mL)

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Meu-cinn group

EXPERIMENTAL

This group takes Meu-cinn for 8 weeks.

Dietary Supplement: Meu-cinn

Placebo group

PLACEBO COMPARATOR

This group takes placebo for 8 weeks.

Dietary Supplement: Placebo

Interventions

Meu-cinn DIETARY_SUPPLEMENT

Meu-cinn 250 mg/day for 8 weeks

Meu-cinn group

Placebo DIETARY_SUPPLEMENT

Placebo 250 mg/day for 8 weeks

Placebo group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rome IV-based functional dyspepsia-

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

RECRUITING

Study Officials

• Sang Yeoup Lee, Professor, MD, PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Yeoup Lee, Professor, MD, PhD

CONTACT

82+55-360-2860; drsaylee@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: December 4, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 3, 2025

Record last verified: 2025-06

Locations

KR (1)