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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mastic gum with dietary modification | Experimental | Mastic gum with dietary modification (for 21 days) |
|
| Dietary modification | Placebo Comparator | Dietary modification (for 21 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mastic gum | Dietary Supplement | Mastic gum 3g/pack daily for 21 days |
|
| 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 |
| 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 |
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1) Inclusion Criteria
2) Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital Clinical Trial Center | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40903850 | Derived | Park J, Huh KY, Chung JY, Yu KS. Methodology for Assessing Patient Centricity and Data Integrity in Clinical Trials With Decentralized Elements: A Pilot Trial on Mastic Gum. Clin Transl Sci. 2025 Sep;18(9):e70343. doi: 10.1111/cts.70343. |
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| ID | Term |
|---|---|
| D000069997 | Mastic Resin |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D012116 | Resins, Plant |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Dietary modification | Behavioral | Adhere to the dietary recommendations for Korean dyspepsia patients |
|
| 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 |
| D044623 |
| Nutrition Therapy |
| D013812 | Therapeutics |