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RecruitingNCT05999500Updated May 22, 2024

The Effectiveness of Temple Stay in Irritable Bowel Syndrome

An observational study in Irritable Bowel Syndrome and Microbial Colonization, sponsored by DongGuk University. Recruiting at 1 site in Korea, Republic of. Open to participants aged 20 Years to 69 Years. Per ClinicalTrials.gov, last updated 2024-05-22.

Sponsored by DongGuk University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
20 Years to 69 Years
Sex
All
01

Study summary

This research is a clinical trial aimed at improving the gut microbiome of patients with Irritable Bowel Syndrome (IBS) through a temple stay experience.

Participants in the study are expected to participate in a temple stay experience for a maximum of 8 days. During the temple stay experience, participants are required to fill out a daily symptom questionnaire related to irritable bowel syndrome and record their diet and bowel movements using a dedicated mobile application. Upon completion of the temple stay, participants will conduct an evaluation of personal satisfaction with the experience.

Through this, the study aims to collect and analyze data related to the Templestay experience with the goal of improving the gut microbiome of patients with IBS.

Read the detailed description

Irritable Bowel Syndrome (IBS) is a syndrome characterized by recurrent abdominal pain accompanied by abdominal discomfort, changes in bowel habits, and abdominal bloating. It is a common condition, affecting approximately 10% of the population in Korea, and its chronic gastrointestinal symptoms significantly impact patients' daily life and quality of life.

Factors such as changes in the intestinal microbiota and the intestinal ecosystem are crucial in its etiology. Modern individuals, who are often exposed to numerous stressors, frequently experience persistent intestinal hypersensitivity and inflammation. Foods that are not well digested and fermented in the intestines, producing a significant amount of gas - such as those rich in seasonings, dairy products, caffeine, and alcohol - are known to trigger symptoms. Therefore, it is suggested that a controlled environment like a Temple Stay, which provides both dietary regulation and stress control, could lead to meaningful symptom improvement. However, there is currently a lack of objective scientific research on this.

Our research team hypothesizes that a Temple Stay experience of more than a week could consistently change the microbiome and stabilize psychosocial factors. This might control chronic intestinal inflammation and hypersensitivity, leading to subjective symptom improvement and enhanced treatment satisfaction for patients.

Through this study, we aim to validate the hypothesis that the dietary changes in a Temple Stay environment will drastically alter patients' dietary intake, enrich the composition of the gut microbiome, and consequently reduce the symptoms of IBS, thereby improving the quality of life.

02

Conditions studied

  • Irritable Bowel Syndrome
  • Microbial Colonization
03

Who can participate

Ages eligible
20 Years to 69 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients aged 20-69 with diarrhea-predominant or constipation-predominant irritable bowel syndrome.

Inclusion criteria

  • Patients aged 20-69 with diarrhea-predominant irritable bowel syndrome

Exclusion criteria

Exclusion Criteria:

  • Monk
  • history of irritable bowel syndrome (constipation-predominant), history of inflammatory bowel disease, history of colorectal cancer, history of gastrointestinal resection,
  • abnormal blood test (liver function test: AST or ALT more than 1.5 times the normal limit, total bilirubin increase of more than 1.5mg/dL, CCr \< 30 mL/min, platelets less than 100,000, PT/aPTT increase of more than 20% of the normal upper limit),
  • uncontrolled hypertension and diabetes
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Irritable bowel syndrome patients participating in temple stay

    We plan to observe a group of patients aged 20-69 with diarrhea-predominant irritable bowel syndrome who have voluntarily agreed to participate in a temple stay for up to 8 days. Observations will be made before the temple stay, immediately after, and then followed up for 4 weeks after the experience.

    Behavioral: Temple stay experience

Interventions

  • BehavioralTemple stay experience

    Temple stay experience includes diet and behavior changes, such as vegetarian meals (ex. Balwoo Gongyang), mindful eating, no overeating, meditation, participation in daily monastic tasks.

05

What researchers measure

Primary outcomes

  1. IBS-SSS

    symptom score for irritable bowel syndrome

    Time frame: before the event, during the event, 4-weeks after the event

Secondary outcomes

  1. Fecal microbiome

    Fecal microbiota composition, microbiome, diversity, Difference in the proportion of the species of primary interest

    Time frame: before the event, during the event, 4-weeks after the event

06

Study locations

1 of 1 sites recruiting
  • Dongguk University Ilsan Hospital
    Goyang, Gyeonggi 10326, Korea, Republic of
    • Sun Young Kim · Contact · ksgesy@naver.com · +82-31-961-7132
    • Jun Kyu Lee · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided — Conditionally considering upon reasonable request.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05999500
Lead sponsor
DongGuk University
Responsible party
Sang Hoon Kim (Assistant professor, Chung-Ang University) — Principal investigator
First posted
Aug 21, 2023
Start date
Jul 1, 2023
Primary completion
Sep 30, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
May 22, 2024

Study contacts

Sang Hoon Kim
Contact
spring0107@naver.com
+82-31-961-7128
Jun Kyu Lee, Prof.
principal investigator · DongGuk University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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