A Study To Evaluate the Feasibility of the Decentralized Clinical Trial in South Korea
- Conditions
- Functional Dyspepsia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Seoul National University Hospital Clinical Trial Center🇰🇷Seoul, Korea, Republic of