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Completed

NCT Number: NCT06005805

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

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?

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Key information

Conditions

Functional Dyspepsia

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital Clinical Trial Center

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.
  • 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.

Treatment and study plan

Mastic gum

Dietary Supplement

Mastic gum 3g/pack daily for 21 days

Dietary Modification

Behavioral

Adhere to the dietary recommendations for Korean dyspepsia patients

Primary outcomes

  1. Specimen delivery time

    Time frame: up to 1 months

    Time from collection at the local laboratory to delivery of specimen and reporting of results

  2. Self-kit success rate

    Time frame: up to 1 months

    Fraction of patients who utilized and delivered a self-test kit on the scheduled date

  3. Adverse event management time

    Time frame: up to 1 months

    In the event of an adverse event requiring medical attention, time from report to response

Secondary outcomes

  1. Self-evaluation questionnaire for dyspepsia (SEQ-DYSPEPSIA) score

    Time frame: 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.

  2. Gut Microbiome Index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 23, 2023
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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