Gut MicrobiotaNCT03153059
Gut Microbiota and Stool Frequency
An observational study of Gut Microbiota, run by Kosin University Gospel Hospital at 1 site in South Korea.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota
- What is being tested?
- Stool frequency
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 May 2017to 30 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers
Who may be able to join
- adults between the age of 20 and 50
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gut Microbiota
- Being tested
- Stool frequency
- Keywords
- gut microbiota, stool frequency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool frequencyOther
This study is just observational study.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | a large number of defecation group (≥ 2-3 times/day) - 20 subjects Receives: Other: Stool frequency | |
| group 2 | normal defecation group (1 time/day or 1 time/2 days) - 20 subjects Receives: Other: Stool frequency | |
| group 3 | a small number of defecation group (≤ 2 times/week) - 20 subjects Receives: Other: Stool frequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
stool frequency and gut microbiota
Analysis of correlation between stool frequency and gut microbiota
Measured: six months
Secondary outcomes (1)
stool consistency and gut microbiota
Analysis of correlation between stool consistency and gut microbiota
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start11 May 2017
- Primary completion30 Sep 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kosin University Gospel Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Hyun Kim, Kosin University Gospel Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153059
- Sponsor's protocol ID
- 2017-02-017-001
- Status last verified
- Dec 2017
- First submitted
- 11 May 2017
- Last updated
- 4 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have no plan to share IPD to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Gut Microbiota and Stool Frequency
- ClinicalTrials.gov ID
- NCT03153059
- Acronym / sponsor ID
- 2017-02-017-001
- Conditions
- Gut Microbiota
- Keywords
- gut microbiota, stool frequency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kosin University Gospel HospitalUniversity, hospital or other
- Study start
- 11 May 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Other: Stool frequencya large number of defecation group (≥ 2-3 times/day) - 20 subjects |
| group 2 | – | Other: Stool frequencynormal defecation group (1 time/day or 1 time/2 days) - 20 subjects |
| group 3 | – | Other: Stool frequencya small number of defecation group (≤ 2 times/week) - 20 subjects |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (1 listed)
- adults between the age of 20 and 50
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool frequencyThis study is just observational study. | Other | group 1, group 2, group 3 |
Primary outcome
stool frequency and gut microbiota
Time frame: six months
Analysis of correlation between stool frequency and gut microbiota
1 secondary outcome
stool consistency and gut microbiota
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
- Individual participant dataSharing planned: No. We have no plan to share IPD to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gut Microbiota, run by Kosin University Gospel Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stool frequency and gut microbiota (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2017.