Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05999500 |
Other study ID # |
TEMPLE |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.