The Effectiveness of Temple Stay in Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05999500
• Other study ID #: TEMPLE
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: DongGuk University
• Contact: Sang Hoon Kim
• Phone: +82-31-961-7128
• Email: spring0107[@]naver.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Gender: All
• Age group: 20 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Irritable Bowel Syndrome
• Microbial Colonization
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Dongguk University Ilsan Hospital	Goyang	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
DongGuk University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IBS-SSS	symptom score for irritable bowel syndrome	before the event, during the event, 4-weeks after the event
Secondary	Fecal microbiome	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