NCT06005805

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

August 21, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

August 6, 2023

Last Update Submit

November 21, 2023

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (3)

  • Specimen delivery time

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

    up to 1 months

  • Self-kit success rate

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

    up to 1 months

  • Adverse event management time

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

    up to 1 months

Secondary Outcomes (2)

  • Self-evaluation questionnaire for dyspepsia (SEQ-DYSPEPSIA) score

    baseline, immediately after the intervention

  • Gut Microbiome Index

    baseline, immediately after the intervention

Study Arms (2)

Mastic gum with dietary modification

EXPERIMENTAL

Mastic gum with dietary modification (for 21 days)

Dietary Supplement: Mastic gumBehavioral: Dietary modification

Dietary modification

PLACEBO COMPARATOR

Dietary modification (for 21 days)

Behavioral: Dietary modification

Interventions

Mastic gumDIETARY_SUPPLEMENT

Mastic gum 3g/pack daily for 21 days

Mastic gum with dietary modification
Dietary modificationBEHAVIORAL

Adhere to the dietary recommendations for Korean dyspepsia patients

Dietary modificationMastic gum with dietary modification

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital Clinical Trial Center

Seoul, 03080, South Korea

Location

Related Publications (1)

  • Park J, Huh KY, Chung JY, Yu KS. Methodology for Assessing Patient Centricity and Data Integrity in Clinical Trials With Decentralized Elements: A Pilot Trial on Mastic Gum. Clin Transl Sci. 2025 Sep;18(9):e70343. doi: 10.1111/cts.70343.

    PMID: 40903850DERIVED

MeSH Terms

Interventions

Mastic ResinDiet Therapy

Intervention Hierarchy (Ancestors)

Resins, PlantPlant ExudatesBiological ProductsComplex MixturesNutrition TherapyTherapeutics

Study Officials

  • Kyung-Sang Yu, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 6, 2023

First Posted

August 23, 2023

Study Start

August 21, 2023

Primary Completion

October 11, 2023

Study Completion

October 31, 2023

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)