Bowel Preparation for Colonoscopy May Lead to a Higher Feasibility of Intestinal Infection: a Clinical and Basic Research
Trial Snapshot
- Phase
- Early Phase 1
- Sponsor
- Enrollment
- 30
- Primary Endpoint
- Polyethyleneglycol could lead to changes in the intestinal flora
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
polyethyleneglycol only
participants take 2L of polyethyleneglycol only
Intervention: 2L of polyethyleneglycol (Drug)
polyethyleneglycol puls Inulin
participants take 2L of polyethyleneglycol, subsequently take 15g inulin per day.
Intervention: 2L of polyethyleneglycol (Drug)
polyethyleneglycol puls Inulin
participants take 2L of polyethyleneglycol, subsequently take 15g inulin per day.
Intervention: inulin (Dietary Supplement)
polyethyleneglycol puls 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.
Intervention: 2L of polyethyleneglycol (Drug)
polyethyleneglycol puls 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.
Intervention: probiotic combination product (Combination Product)
Outcomes
Primary Outcomes
Polyethyleneglycol could lead to changes in the intestinal flora
Time Frame: one year(from 15/3/2022 to 15/3/2023)
People with polyethyleneglycol administration will lead to a decrease of intestinal flora quantity
Secondary Outcomes
- inulin and probiotics could improve the recovery of gut microbiota(one year(from 15/3/2022 to 15/3/2023))
Investigators
Yanqing Li
Professor
Shandong University