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Completed

NCT Number: NCT03760133

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

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.

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Key information

Conditions

Gut Microbiota Bowel Preparation Colonoscopy

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kosin University Gospel Hospital

Busan, 49267, South Korea

About this study

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

  • with probiotics group - 50 subjects
  • Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.
  • without probiotics group - 50 subjects
  • Participants included in this group will not be taken probiotics for 1 month after bowel preparation for colonoscopy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duolac

Drug

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

Primary outcomes

  1. The effect of probiotics on the change of gut microbiota after bowel preparation.

    Time frame: eight months

    Analysis the change of gut microbiota before and after bowel preparation for colonoscopy, and the effect of probiotics.

Secondary outcomes

  1. The occurrence of symptoms

    Time frame: eight months

    Analysis the occurrence of symptoms including abdominal discomfort, diarrhea, constipation or abdominal blotting after bowel preparation for colonoscopy.

  2. The correlation between symptoms and gut microbiota..

    Time frame: eight months

    Analysis the the correlation between the symptoms after bowel preparation for colonoscopy and the changes of gut microbiota.

Sponsors and collaborators

Lead sponsor

Kosin University Gospel Hospital

Other

Collaborators

  • Cell Biotech Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 30, 2018
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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