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The Effectiveness of Temple Stay in Irritable Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT05999500
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : April 16, 2024
Sponsor:
Information provided by (Responsible Party):
Sang Hoon Kim, Chung-Ang University

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Irritable Bowel Syndrome Microbial Colonization Behavioral: Temple stay experience

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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Temple Stay Improves Intestinal Microbiome Profile in Patients With Irritable Bowel Syndrome
Estimated Study Start Date : May 1, 2024
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : December 31, 2024
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. IBS-SSS [ Time Frame: before the event, during the event, 4-weeks after the event ]
    symptom score for irritable bowel syndrome


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples Without DNA
Feces

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients aged 20-69 with diarrhea-predominant or constipation-predominant irritable bowel syndrome.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05999500


Contacts
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Contact: Sang Hoon Kim +82-31-961-7128 spring0107@naver.com

Locations
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Korea, Republic of
Dongguk University Ilsan Hospital Recruiting
Goyang, Gyeonggi, Korea, Republic of, 10326
Contact: Sun Young Kim    +82-31-961-7132    ksgesy@naver.com   
Principal Investigator: Jun Kyu Lee         
Sponsors and Collaborators
DongGuk University
Investigators
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Principal Investigator: Jun Kyu Lee, Prof. DongGuk University
More Information
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Responsible Party: Sang Hoon Kim, Assistant professor, Chung-Ang University
ClinicalTrials.gov Identifier: NCT05999500    
Other Study ID Numbers: TEMPLE
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: April 16, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Conditionally considering upon reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infections
Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
 Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Disease Attributes