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

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

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy; Bowel Preparation; Gut Microbiota
• Intervention / Treatment: Drug: Duolac

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 49267
    • Kosin University Gospel Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: with Probiotics; Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.	Drug: Duolac; Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.
NO_INTERVENTION: without Probiotics; Participants included in this group will not be taken probiotics for 1 month after bowel preparation for colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The occurrence of symptoms	Analysis the occurrence of symptoms including abdominal discomfort, diarrhea, constipation or abdominal blotting after bowel preparation for colonoscopy.	eight months
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

Collaborators and Investigators

• Sponsor: Kosin University Gospel Hospital
• Collaborators: Cell Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2018
• Primary Completion (ACTUAL): November 30, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: November 25, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (ACTUAL): November 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Probiotics; Colonoscopy; Gut microbiota; Bowel preparation
• Other Study ID Numbers: 2018-07-024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators have no plan to share IPD to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No