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NCT03760133 Clinical Trial

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

Colonoscopy Clinical Trial

Official title:
The Change of Gut Microbiota After Bowel Preparation and the Effect of Probiotics: Randomized Controlled, Open-label Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03760133
Other study ID # 2018-07-024
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 1, 2018
Est. completion date December 31, 2019

Study information
Verified date February 2020
Source Kosin University Gospel Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 31, 2019
Est. primary completion date November 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Kosin University Gospel Hospital Busan

Sponsors (2)
Lead Sponsor Collaborator
Kosin University Gospel Hospital Cell Biotech Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The effect of probiotics on the change of gut microbiota after bowel preparation. Analysis the change of gut microbiota before and after bowel preparation for colonoscopy, and the effect of probiotics. eight months
Secondary The occurrence of symptoms Analysis the occurrence of symptoms including abdominal discomfort, diarrhea, constipation or abdominal blotting after bowel preparation for colonoscopy. eight months
Secondary The correlation between symptoms and gut microbiota.. Analysis the the correlation between the symptoms after bowel preparation for colonoscopy and the changes of gut microbiota. eight months
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