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

• ClinicalTrials.gov Identifier: NCT06005805
• Recruitment Status: Completed
• First Posted: August 23, 2023
• Last Update Posted: November 22, 2023
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Kyung-Sang Yu, Seoul National University Hospital

Study Description

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?

Condition or disease	Intervention/treatment	Phase
Functional Dyspepsia	Dietary Supplement: Mastic gum; Behavioral: Dietary modification	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: August 21, 2023
• Actual Primary Completion Date: October 11, 2023
• Actual Study Completion Date: October 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Self-evaluation questionnaire for dyspepsia (SEQ-DYSPEPSIA) score [ Time Frame: 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.
2. Gut Microbiome Index [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Korea, Republic of

Seoul National University Hospital Clinical Trial Center

Seoul, Korea, Republic of, 03080

Sponsors and Collaborators

Seoul National University Hospital

Investigators

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

More Information

• Responsible Party: Kyung-Sang Yu, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT06005805
• Other Study ID Numbers: DCT-102
• First Posted: August 23, 2023
• Last Update Posted: November 22, 2023
• Last Verified: November 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dyspepsia; Signs and Symptoms, Digestive