A Study To Evaluate the Feasibility of the Decentralized Clinical Trial in South Korea

Functional Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06005805
• Other study ID #: DCT-102
• Status: Completed
• Phase: N/A
• Start date: August 21, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 31, 2023
• Est. primary completion date: October 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

Intervention

Dietary Supplement:
• Mastic gum
Mastic gum 3g/pack daily for 21 days

Behavioral:
• Dietary modification
Adhere to the dietary recommendations for Korean dyspepsia patients

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital Clinical Trial Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specimen delivery time	Time from collection at the local laboratory to delivery of specimen and reporting of results	up to 1 months
Primary	Self-kit success rate	Fraction of patients who utilized and delivered a self-test kit on the scheduled date	up to 1 months
Primary	Adverse event management time	In the event of an adverse event requiring medical attention, time from report to response	up to 1 months
Secondary	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
Secondary	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