Back to resultsA Study To Evaluate the Feasibility of the Decentralized Clinical Trial in South Korea
Primary Purpose
Functional Dyspepsia
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mastic gum
Dietary modification
Sponsored by
About this trial
This is an interventional treatment trial for Functional Dyspepsia
Eligibility Criteria
1) 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. 2) Exclusion Criteria 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.
Sites / Locations
- Seoul National University Hospital Clinical Trial CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Mastic gum with dietary modification
Dietary modification
Arm Description
Mastic gum with dietary modification (for 21 days)
Dietary modification (for 21 days)
Outcomes
Primary Outcome Measures
Specimen delivery time
Time from collection at the local laboratory to delivery of specimen and reporting of results
Self-kit success rate
Fraction of patients who utilized and delivered a self-test kit on the scheduled date
Adverse event management time
In the event of an adverse event requiring medical attention, time from report to response
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT06005805
First Posted
August 6, 2023
Last Updated
August 22, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06005805
Brief Title
A Study To Evaluate the Feasibility of the Decentralized Clinical Trial in South Korea
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mastic gum with dietary modification
Arm Type
Experimental
Arm Description
Mastic gum with dietary modification (for 21 days)
Arm Title
Dietary modification
Arm Type
Placebo Comparator
Arm Description
Dietary modification (for 21 days)
Intervention Type
Dietary Supplement
Intervention Name(s)
Mastic gum
Intervention Description
Mastic gum 3g/pack daily for 21 days
Intervention Type
Behavioral
Intervention Name(s)
Dietary modification
Intervention Description
Adhere to the dietary recommendations for Korean dyspepsia patients
Primary Outcome Measure Information:
Title
Specimen delivery time
Description
Time from collection at the local laboratory to delivery of specimen and reporting of results
Time Frame
up to 1 months
Title
Self-kit success rate
Description
Fraction of patients who utilized and delivered a self-test kit on the scheduled date
Time Frame
up to 1 months
Title
Adverse event management time
Description
In the event of an adverse event requiring medical attention, time from report to response
Time Frame
up to 1 months
Secondary Outcome Measure Information:
Title
Self-evaluation questionnaire for dyspepsia (SEQ-DYSPEPSIA) score
Description
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.
Time Frame
baseline, immediately after the intervention
Title
Gut Microbiome Index
Description
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.
Time Frame
baseline, immediately after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
1) 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.
2) Exclusion Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiyeon Park, MD
Phone
+82 2 2072 1666
Email
creativepennant@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung-Sang Yu, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital Clinical Trial Center
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiyeon Park, MD
Phone
+82 2 2072 1666
Email
creativepennant@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Kyung-Sang Yu, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study To Evaluate the Feasibility of the Decentralized Clinical Trial in South Korea
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