A Study To Evaluate the Feasibility of the Decentralized Clinical Trial in South Korea
Study Details
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:
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Does decentralized elements feasible in Korea?
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Does Mastic gum alleviates symptoms and modifies stool microbiome in Korean patients with functional dyspepsia?
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
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
- Specimen delivery time [up to 1 months]
Time from collection at the local laboratory to delivery of specimen and reporting of results
- 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
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
- Inclusion Criteria
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Adults aged 19 to 75 years old at the time of consent.
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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.
- Exclusion Criteria
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Those with symptoms (dysphagia, severe dysphagia, bleeding, weight loss, anemia, bloody stools) that may suggest a malignant disease of the gastrointestinal tract.
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Subjects with a diagnosis of eosinophilic esophagitis or a history of eosinophilic esophagitis.
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Have or have had clinically significant hepatic, renal, neurologic, respiratory, endocrine, hematologic and oncologic, cardiovascular, urinary, or psychiatric disease.
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Pregnant or lactating women
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Have or have had a history of clinically significant hypersensitivity to the dietary supplement to be administered.
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Aspartate aminotransferase or alanine aminotransferase greater than 5 times the upper limit of normal range on screening tests
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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.
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Those deemed by the investigator to be unsuitable for participation in the clinical trial due to other reasons.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DCT-102