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

Phase 2

Completed

• Conditions: Gut Microbiota; Colonoscopy; Bowel Preparation
• Interventions: Drug: Duolac

• Registration Number: NCT03760133
• Lead Sponsor: Kosin University Gospel Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-11-25
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-30
• Study Start: 2018-12-01
• Primary Completion: 2019-11-30
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with Probiotics	Duolac	Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.

Primary Outcome Measures

Name	Time	Method
The effect of probiotics on the change of gut microbiota after bowel preparation.	eight months	Analysis the change of gut microbiota before and after bowel preparation for colonoscopy, and the effect of probiotics.

Secondary Outcome Measures

Name	Time	Method
The occurrence of symptoms	eight months	Analysis the occurrence of symptoms including abdominal discomfort, diarrhea, constipation or abdominal blotting after bowel preparation for colonoscopy.
The correlation between symptoms and gut microbiota..	eight months	Analysis the the correlation between the symptoms after bowel preparation for colonoscopy and the changes of gut microbiota.

Trial Locations

Locations (1)

Kosin University Gospel Hospital; 🇰🇷 Busan, Korea, Republic of