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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gut Microbiota, Bowel Preparation, Colonoscopy

Intervention / Treatment
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* Drug: Duolac


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: with Probiotics<br>Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy. | Drug: Duolac<br>* Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.<br>|
| No Intervention: without Probiotics<br>Participants included in this group will not be taken probiotics for 1 month after bowel preparation for colonoscopy. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut microbiota, Colonoscopy, Bowel preparation, Probiotics