The Effectiveness of Temple Stay in Irritable Bowel Syndrome

April 14, 2024 updated by: Sang Hoon Kim, DongGuk University

Temple Stay Improves Intestinal Microbiome Profile in Patients With Irritable Bowel Syndrome

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Goyang, Gyeonggi, Korea, Republic of, 10326
        • Recruiting
        • Dongguk University Ilsan Hospital
        • Contact:
        • Principal Investigator:
          • Jun Kyu Lee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IBS-SSS
Time Frame: before the event, during the event, 4-weeks after the event
symptom score for irritable bowel syndrome
before the event, during the event, 4-weeks after the event

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal microbiome
Time Frame: before the event, during the event, 4-weeks after the event
Fecal microbiota composition, microbiome, diversity, Difference in the proportion of the species of primary interest
before the event, during the event, 4-weeks after the event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DongGuk University

Investigators

  • Principal Investigator: Jun Kyu Lee, Prof., DongGuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 11, 2023

First Submitted That Met QC Criteria

August 11, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 14, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEMPLE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Conditionally considering upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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