NCT06005805

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Mastic gum	Mastic gum 3g/pack daily for 21 days
BEHAVIORAL	Dietary modification	Adhere to the dietary recommendations for Korean dyspepsia patients

Timeline

• Start date: 2023-08-21
• Primary completion: 2023-10-11
• Completion: 2023-10-31
• First posted: 2023-08-23
• Last updated: 2023-11-22

Locations

1 site across 1 country: South Korea