Bowel Preparation May Lead to a Higher Feasibility of Intestinal Infection

Early Phase 1

• Conditions: Healthy
• Interventions: Drug: 2L of polyethyleneglycol; Dietary Supplement: inulin; Combination Product: probiotic combination product

• Registration Number: NCT05277090
• Lead Sponsor: Yanqing Li

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-19
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-02
• Last Update Submitted: 2022-03-02
• Study First Posted: 2022-03-14
• Last Update Posted: 2022-03-14
• Study Start: 2022-03-15
• Primary Completion: 2022-03-15
• Study Completion: 2022-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
polyethyleneglycol only	2L of polyethyleneglycol	participants take 2L of polyethyleneglycol only
polyethyleneglycol puls Inulin	inulin	participants take 2L of polyethyleneglycol, subsequently take 15g inulin per day.
polyethyleneglycol puls probiotic combination product	2L of polyethyleneglycol	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.
polyethyleneglycol puls Inulin	2L of polyethyleneglycol	participants take 2L of polyethyleneglycol, subsequently take 15g inulin per day.
polyethyleneglycol puls probiotic combination product	probiotic combination product	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.

Primary Outcome Measures

Name	Time	Method
Polyethyleneglycol could lead to changes in the intestinal flora	one year(from 15/3/2022 to 15/3/2023)	People with polyethyleneglycol administration will lead to a decrease of intestinal flora quantity

Secondary Outcome Measures

Name	Time	Method
inulin and probiotics could improve the recovery of gut microbiota	one year(from 15/3/2022 to 15/3/2023)	inulin and probiotics will improve the recovery of flora quantity after Polyethyleneglycol administration