Functional Dyspepsia
Conditions
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?
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.
Interventions
DIETARY_SUPPLEMENTMastic gum
Mastic gum 3g/pack daily for 21 days
BEHAVIORALDietary modification
Adhere to the dietary recommendations for Korean dyspepsia patients
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed