Bowel Preparation May Lead to a Higher Feasibility of Intestinal Infection

Study Overview
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Brief Summary
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An adequate bowel preparation is essential for a high quality of colonscopy. Nowdays, polyethyleneglyco is considered the most safe drug for bowel preparation, and is widely used around the world. However, previous study illustrated that bowel preparation by polyethyleneglyco could lead to qualitative changes in the intestinal microbiota both in mice and human. This study is aimed to investigate wether the changes in the intestinal microbiota could lead to a higher rate of intestinal infection.

Official Title
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Bowel Preparation for Colonoscopy May Lead to a Higher Feasibility of Intestinal Infection: a Clinical and Basic Research

Conditions
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Healthy

Intervention / Treatment
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* Drug: 2L of polyethyleneglycol
* Dietary Supplement: inulin
* Combination Product: probiotic combination product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who agree to participant in the study Exclusion Criteria: patients who couldn't stand polyethyleneglycol or inulin patients couldn't provide Informed consent patients who are suffering from sever heart disease, pulmonary disease or renal dysfunction.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: polyethyleneglycol only<br>participants take 2L of polyethyleneglycol only | Drug: 2L of polyethyleneglycol<br>* 2L of polyethyleneglycol<br>|
| Experimental: polyethyleneglycol puls Inulin<br>participants take 2L of polyethyleneglycol, subsequently take 15g inulin per day. | Drug: 2L of polyethyleneglycol<br>* 2L of polyethyleneglycol<br>Dietary Supplement: inulin<br>* 15g inulin per day<br>|
| Experimental: polyethyleneglycol puls probiotic combination product<br>Participants take 2L of polyethyleneglycol, subsequently take 15g probiotics combination product (including Bifidobacterium lactis, Lactobacillus plantarum, inlulin, Vitamin C) per day. The probiotic combination product, named Mei Ri Yi Jun was produced by Wedge Pharmaceuticals. | Drug: 2L of polyethyleneglycol<br>* 2L of polyethyleneglycol<br>Combination Product: probiotic combination product<br>* participants take 2L of polyethyleneglycol, subsequently take 15g probiotics combination product (including Bifidobacterium lactis, Lactobacillus plantarum, inlulin, Vitamin C) per day. The probiotic combination product, named Mei Ri Yi Jun was produced by Wedge Pharmaceuticals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyethyleneglycol could lead to changes in the intestinal flora | People with polyethyleneglycol administration will lead to a decrease of intestinal flora quantity | one year(from 15/3/2022 to 15/3/2023) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inulin and probiotics could improve the recovery of gut microbiota | inulin and probiotics will improve the recovery of flora quantity after Polyethyleneglycol administration | one year(from 15/3/2022 to 15/3/2023) |