NCT03153059

Brief 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). And we investigate the association between gut microbiota and stool frequency.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

May 11, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
Last Updated

December 4, 2017

Status Verified

December 1, 2017

Enrollment Period

5 months

First QC Date

May 11, 2017

Last Update Submit

December 1, 2017

Conditions

Keywords

gut microbiotastool frequency

Outcome Measures

Primary Outcomes (1)

  • stool frequency and gut microbiota

    Analysis of correlation between stool frequency and gut microbiota

    six months

Secondary Outcomes (1)

  • stool consistency and gut microbiota

    six months

Study Arms (3)

group 1

a large number of defecation group (≥ 2-3 times/day) - 20 subjects

Other: Stool frequency

group 2

normal defecation group (1 time/day or 1 time/2 days) - 20 subjects

Other: Stool frequency

group 3

a small number of defecation group (≤ 2 times/week) - 20 subjects

Other: Stool frequency

Interventions

This study is just observational study.

group 1group 2group 3

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy volunteers

You may qualify if:

  • adults between the age of 20 and 50

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kosin University Gospel Hospital

Busan, 49267, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

We will collect the stool from participants, and extract DNA from stool sample. We plan to acquire the Human Derivative Research Description.

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The association between gut microbiota and stool frequency

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 15, 2017

Study Start

May 11, 2017

Primary Completion

September 30, 2017

Study Completion

October 30, 2017

Last Updated

December 4, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

We have no plan to share IPD to other researchers.

Locations