The Effectiveness of Temple Stay in Irritable Bowel Syndrome

Sponsor
DongGuk University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05999500
Collaborator
(none)
100
1
18
5.5

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Temple Stay Improves Intestinal Microbiome Profile in Patients With Irritable Bowel Syndrome
Actual Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. IBS-SSS [before the event, during the event, 4-weeks after the event]

    symptom score for irritable bowel syndrome

Secondary Outcome Measures

  1. Fecal microbiome [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 69 Years
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 Dongguk University Ilsan Hospital Goyang Gyeonggi Korea, Republic of 10326

Sponsors and Collaborators

  • DongGuk University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sang Hoon Kim, Assistant professor, DongGuk University
ClinicalTrials.gov Identifier:
NCT05999500
Other Study ID Numbers:
  • TEMPLE
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2023