The Change of Gut Microbiota After Bowel Preparation and the Effect of Probiotics

NCT ID: NCT03760133

Last Updated: 2020-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-12-31

Brief Summary

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The purpose of this study is to investigate the relationship between the change of intestinal bacterial flora and the recovery, and the incidence of symptoms such as abdominal discomfort after colonoscopy. And the investigators will also analyze the effects of probiotics on the degree of change, recovery, and symptom development in intestinal flora.

Detailed Description

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The investigators divided two groups. (total number = 100 subjects)

1. with probiotics group - 50 subjects

* Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.
2. without probiotics group - 50 subjects

* Participants included in this group will not be taken probiotics for 1 month after bowel preparation for colonoscopy.

Conditions

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Gut Microbiota Bowel Preparation Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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with Probiotics

Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.

Group Type ACTIVE_COMPARATOR

Duolac

Intervention Type DRUG

Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.

without Probiotics

Participants included in this group will not be taken probiotics for 1 month after bowel preparation for colonoscopy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Duolac

Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adults between the age of 30 and 70

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cell Biotech Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Kosin University Gospel Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jae Hyun Kim

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kosin University Gospel Hospital

Busan, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2018-07-024

Identifier Type: -

Identifier Source: org_study_id

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