The Effectiveness of Temple Stay in Irritable Bowel Syndrome

NCT05999500 | Recruiting DMC

• 1 other identifier: TEMPLE
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome; Microbial Colonization

Outcome Measures

Primary Outcomes (1)

• IBS-SSS

  symptom score for irritable bowel syndrome

  before the event, during the event, 4-weeks after the event

Secondary Outcomes (1)

• Fecal microbiome

  before the event, during the event, 4-weeks after the event

Study Arms (1)

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

Temple stay experience BEHAVIORAL

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.

Irritable bowel syndrome patients participating in temple stay

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• DongGuk University: lead

Study Sites (1)

Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, 10326, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Feces

MeSH Terms

Conditions

Irritable Bowel Syndrome; Communicable Diseases

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jun Kyu Lee, Prof.

  DongGuk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Hoon Kim

CONTACT

+82-31-961-7128; spring0107@naver.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 21, 2023
• Study Start: July 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

KR (1)