- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03153059
Gut Microbiota and Stool Frequency
The Association Between Gut Microbiota and Stool Frequency
We hypothesized that some difference in the composition and distribution of gut microbiota in people with a large number of defecation (two or three times a day or more), people with normal defecation (one time a day or two days), and people with a small number of defecation (two times a week or less).
And we investigate the association between gut microbiota and stool frequency.
Study Overview
Detailed Description
We divided three groups. (total number = 60 subjects)
- a large number of defecation group (≥ 2-3 times/day) - 20 subjects
- normal defecation group (1 time/day or 1 time/2 days) - 20 subjects
- a small number of defecation group (≤ 2 times/week) - 20 subjects
After collection of stools, we will analyze the composition and distribution of gut microbiota, and compared the results of three groups.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Busan, Korea, Republic of, 49267
- Kosin University Gospel Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- adults between the age of 20 and 50
Exclusion Criteria:
- subjects with cancer or IBD (inflammatory bowel disease)
- subjects with history of abdominal surgery
- subjects who take medication related to gastrointestinal motility within 3 months
- subjects who take antibiotics within 3 months
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
group 1
a large number of defecation group (≥ 2-3 times/day) - 20 subjects
|
This study is just observational study.
|
|
group 2
normal defecation group (1 time/day or 1 time/2 days) - 20 subjects
|
This study is just observational study.
|
|
group 3
a small number of defecation group (≤ 2 times/week) - 20 subjects
|
This study is just observational study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
stool frequency and gut microbiota
Time Frame: six months
|
Analysis of correlation between stool frequency and gut microbiota
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
stool consistency and gut microbiota
Time Frame: six months
|
Analysis of correlation between stool consistency and gut microbiota
|
six months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2017-02-017-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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