Bowel Preparation May Lead to a Higher Feasibility of Intestinal Infection
March 2, 2022 updated by: Yanqing Li
Bowel Preparation for Colonoscopy May Lead to a Higher Feasibility of Intestinal Infection: a Clinical and Basic Research
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Early Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 56 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: polyethyleneglycol only
participants take 2L of polyethyleneglycol only
|
2L of polyethyleneglycol
|
|
Experimental: polyethyleneglycol puls Inulin
participants take 2L of polyethyleneglycol, subsequently take 15g inulin per day.
|
2L of polyethyleneglycol
15g inulin per day
|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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
Time Frame: one year(from 15/3/2022 to 15/3/2023)
|
inulin and probiotics will improve the recovery of flora quantity after Polyethyleneglycol administration
|
one year(from 15/3/2022 to 15/3/2023)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Guanjun Kou, Qilu Hospital of Shandong University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 15, 2022
Primary Completion (Anticipated)
March 15, 2022
Study Completion (Anticipated)
March 15, 2022
Study Registration Dates
First Submitted
October 19, 2021
First Submitted That Met QC Criteria
March 2, 2022
First Posted (Actual)
March 14, 2022
Study Record Updates
Last Update Posted (Actual)
March 14, 2022
Last Update Submitted That Met QC Criteria
March 2, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-SDU-QILU-088
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.