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

NCT03760133 | Completed Phase 2

• 1 other identifier: 2018-07-024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Microbiota; Bowel Preparation; Colonoscopy

Keywords

Gut microbiota; Colonoscopy; Bowel preparation; Probiotics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The occurrence of symptoms

  eight months

• The correlation between symptoms and gut microbiota..

  eight months

Study Arms (2)

with Probiotics

ACTIVE COMPARATOR

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

Drug: Duolac

without Probiotics

NO INTERVENTION

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

Interventions

Duolac DRUG

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

with Probiotics

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults between the age of 30 and 70

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

Sponsors & Collaborators

• Kosin University Gospel Hospital: lead
• Cell Biotech Co., Ltd.: collaborator

Study Sites (1)

Kosin University Gospel Hospital

Busan, 49267, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 25, 2018
• First Posted: November 30, 2018
• Study Start: December 1, 2018
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)