Gut Microbiota and Stool Frequency

December 1, 2017 updated by: Jae Hyun Kim, Kosin University Gospel Hospital

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

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We divided three groups. (total number = 60 subjects)

  1. a large number of defecation group (≥ 2-3 times/day) - 20 subjects
  2. normal defecation group (1 time/day or 1 time/2 days) - 20 subjects
  3. 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

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy volunteers

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2017

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

October 30, 2017

Study Registration Dates

First Submitted

May 11, 2017

First Submitted That Met QC Criteria

May 11, 2017

First Posted (Actual)

May 15, 2017

Study Record Updates

Last Update Posted (Actual)

December 4, 2017

Last Update Submitted That Met QC Criteria

December 1, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2017-02-017-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We have no plan to share IPD to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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