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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Self-kit success rate
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria
- •Adults aged 19 to 75 years old at the time of consent.
- •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.
排除标准
- •Those with symptoms (dysphagia, severe dysphagia, bleeding, weight loss, anemia, bloody stools) that may suggest a malignant disease of the gastrointestinal tract.
- •Subjects with a diagnosis of eosinophilic esophagitis or a history of eosinophilic esophagitis.
- •Have or have had clinically significant hepatic, renal, neurologic, respiratory, endocrine, hematologic and oncologic, cardiovascular, urinary, or psychiatric disease.
- •Pregnant or lactating women
- •Have or have had a history of clinically significant hypersensitivity to the dietary supplement to be administered.
- •Aspartate aminotransferase or alanine aminotransferase greater than 5 times the upper limit of normal range on screening tests
- •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.
- •Those deemed by the investigator to be unsuitable for participation in the clinical trial due to other reasons.
研究组 & 干预措施
Mastic gum with dietary modification
Mastic gum with dietary modification (for 21 days)
干预措施: Mastic gum (Dietary Supplement)
Mastic gum with dietary modification
Mastic gum with dietary modification (for 21 days)
干预措施: Dietary modification (Behavioral)
Dietary modification
Dietary modification (for 21 days)
干预措施: Dietary modification (Behavioral)
结局指标
主要结局
Self-kit success rate
时间窗: up to 1 months
Fraction of patients who utilized and delivered a self-test kit on the scheduled date
Adverse event management time
时间窗: up to 1 months
In the event of an adverse event requiring medical attention, time from report to response
Specimen delivery time
时间窗: up to 1 months
Time from collection at the local laboratory to delivery of specimen and reporting of results
次要结局
- Self-evaluation questionnaire for dyspepsia (SEQ-DYSPEPSIA) score(baseline, immediately after the intervention)
- Gut Microbiome Index(baseline, immediately after the intervention)
研究者
Kyung-Sang Yu
Professor
Seoul National University Hospital