A Study To Evaluate the Feasibility of the Decentralized Clinical Trial in South Korea
NCT ID: NCT06005805
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2023-08-21
2023-10-31
Brief Summary
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* Does decentralized elements feasible in Korea?
* Does Mastic gum alleviates symptoms and modifies stool microbiome in Korean patients with functional dyspepsia?
Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mastic gum with dietary modification
Mastic gum with dietary modification (for 21 days)
Mastic gum
Mastic gum 3g/pack daily for 21 days
Dietary modification
Adhere to the dietary recommendations for Korean dyspepsia patients
Dietary modification
Dietary modification (for 21 days)
Dietary modification
Adhere to the dietary recommendations for Korean dyspepsia patients
Interventions
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Mastic gum
Mastic gum 3g/pack daily for 21 days
Dietary modification
Adhere to the dietary recommendations for Korean dyspepsia patients
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
19 Years
75 Years
ALL
Yes
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Kyung-Sang Yu
Professor
Principal Investigators
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Kyung-Sang Yu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital Clinical Trial Center
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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DCT-102
Identifier Type: -
Identifier Source: org_study_id