A Study To Evaluate the Feasibility of the Decentralized Clinical Trial in South Korea

Study Overview
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Brief Summary
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The goal of this study is to evaluate the feasibility of a decentralized clinical trial in South Korea. The main questions it aims to answer are: Does decentralized elements feasible in Korea? Does Mastic gum alleviates symptoms and modifies stool microbiome in Korean patients with functional dyspepsia?

Detailed Description
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The trial aims to evaluate decentralized elements in South Korea, including clinical laboratory testing using local laboratories, medication adherence assessment using wearable devices, analysis of self-kit specimens, delivery and tracking of investigational medication, real-time remote interview of subjects and e-consent acquisition. Mastic gum is registered with the Ministry of Food and Drug Safety in South Korea as a dietary supplement for gastric health, and the study aims to explore the effect on the gastrointestinal symptoms and composition of the stool microbiome.

Official Title
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A Study To Evaluate the Feasibility of the Decentralized Clinical Trial in South Korea: to Evaluate the Effect of Mastic Gum in Participants With Functional Dyspepsia Symptoms

Conditions
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Functional Dyspepsia

Intervention / Treatment
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* Dietary Supplement: Mastic gum
* Behavioral: Dietary modification


Participation Criteria
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Eligibility Criteria
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1) Inclusion Criteria Adults aged 19 to 75 years old at the time of consent. The sum of the intensity and frequency score of the six major symptoms (epigastric pain, early satiety, postprandial fullness, bloating, belching and nausea) of the self-evaluation questionnaire for dyspepsia (SEQ-DYSPEPSIA) is 12 or more. 2) Exclusion Criteria Those with symptoms (dysphagia, severe dysphagia, bleeding, weight loss, anemia, bloody stools) that may suggest a malignant disease of the gastrointestinal tract. Subjects with a diagnosis of eosinophilic esophagitis or a history of eosinophilic esophagitis. Have or have had clinically significant hepatic, renal, neurologic, respiratory, endocrine, hematologic and oncologic, cardiovascular, urinary, or psychiatric disease. Pregnant or lactating women Have or have had a history of clinically significant hypersensitivity to the dietary supplement to be administered. Aspartate aminotransferase or alanine aminotransferase greater than 5 times the upper limit of normal range on screening tests Subjects who are expected to take other medications within the study period that may affect the evaluation of the effectiveness of the study substance (gastrointestinal motility promoters, acid secretagogues, proton pump inhibitors, nonsteroidal anti-inflammatory drugs, anticholinergics, erythromycin, corticosteroids, antidepressants, etc. Those deemed by the investigator to be unsuitable for participation in the clinical trial due to other reasons.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mastic gum with dietary modification<br>Mastic gum with dietary modification (for 21 days) | Dietary Supplement: Mastic gum<br>* Mastic gum 3g/pack daily for 21 days<br>Behavioral: Dietary modification<br>* Adhere to the dietary recommendations for Korean dyspepsia patients<br>|
| Placebo Comparator: Dietary modification<br>Dietary modification (for 21 days) | Behavioral: Dietary modification<br>* Adhere to the dietary recommendations for Korean dyspepsia patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specimen delivery time | Time from collection at the local laboratory to delivery of specimen and reporting of results | up to 1 months | 
| Self-kit success rate | Fraction of patients who utilized and delivered a self-test kit on the scheduled date | up to 1 months | 
| Adverse event management time | In the event of an adverse event requiring medical attention, time from report to response | up to 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-evaluation questionnaire for dyspepsia (SEQ-DYSPEPSIA) score | A self-evaluation questionnaire for dyspepsia score comprised 11 symptoms. Each symptom is measured on a 5-point scale for both frequency and intensity. The total score range from 22 to 110 and higher scores mean a worse outcome. | baseline, immediately after the intervention | 
| Gut Microbiome Index | An index that combines microbial diversity, the proportion of pro-inflammatory microbes, the proportion of microbes that produce anti-inflammatory substances, and similarity to hunter-gatherers. | baseline, immediately after the intervention |