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

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?

Study Overview

• Status: Completed
• Conditions: Functional Dyspepsia
• Intervention / Treatment: Dietary supplement: Mastic gum; Behavioral: Dietary modification

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiyeon Park, MD; Phone Number: +82 2 2072 1666; Email: creativepennant@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital Clinical Trial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

1) Inclusion Criteria

1. Adults aged 19 to 75 years old at the time of consent.
2. 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

1. Those with symptoms (dysphagia, severe dysphagia, bleeding, weight loss, anemia, bloody stools) that may suggest a malignant disease of the gastrointestinal tract.
2. Subjects with a diagnosis of eosinophilic esophagitis or a history of eosinophilic esophagitis.
3. Have or have had clinically significant hepatic, renal, neurologic, respiratory, endocrine, hematologic and oncologic, cardiovascular, urinary, or psychiatric disease.
4. Pregnant or lactating women
5. Have or have had a history of clinically significant hypersensitivity to the dietary supplement to be administered.
6. Aspartate aminotransferase or alanine aminotransferase greater than 5 times the upper limit of normal range on screening tests
7. 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.
8. Those deemed by the investigator to be unsuitable for participation in the clinical trial due to other reasons.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mastic gum with dietary modification; Mastic gum with dietary modification (for 21 days)	Dietary supplement: Mastic gum; Mastic gum 3g/pack daily for 21 days; Behavioral: Dietary modification; Adhere to the dietary recommendations for Korean dyspepsia patients
Placebo Comparator: Dietary modification; Dietary modification (for 21 days)	Behavioral: Dietary modification; Adhere to the dietary recommendations for Korean dyspepsia patients

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Kyung-Sang Yu, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Actual): October 11, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: August 6, 2023
• First Submitted That Met QC Criteria: August 19, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: DCT-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No