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

Pusan National University Yangsan Hospital

Status: Enrolling

Conditions: Functioanl Dyspepsia

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Meu-cinn

Study type: Interventional

Funder types: Other

Identifiers

NCT06630455

12-2024-009

Details and patient eligibility

About

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?

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Meu-cinn group

Experimental group

Description:

This group takes Meu-cinn for 8 weeks.

Treatment:

Dietary Supplement: Meu-cinn

Placebo group

Placebo Comparator group

Description:

This group takes placebo for 8 weeks.

Treatment:

Dietary Supplement: Placebo