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

Not Applicable

Completed

• Conditions: Functional Dyspepsia
• Interventions: Behavioral: Dietary modification; Dietary Supplement: Mastic gum

• Registration Number: NCT06005805
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-08-06
• Study First Submitted QC: 2023-08-19
• Study Start: 2023-08-21
• Study First Posted: 2023-08-23
• Primary Completion: 2023-10-11
• Study Completion: 2023-10-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary modification	Dietary modification	Dietary modification (for 21 days)
Mastic gum with dietary modification	Dietary modification	Mastic gum with dietary modification (for 21 days)
Mastic gum with dietary modification	Mastic gum	Mastic gum with dietary modification (for 21 days)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Self-evaluation questionnaire for dyspepsia (SEQ-DYSPEPSIA) score	baseline, immediately after the intervention	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.
Gut Microbiome Index	baseline, immediately after the intervention	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.

Trial Locations

Locations (1)

Seoul National University Hospital Clinical Trial Center; 🇰🇷 Seoul, Korea, Republic of