Bowel Preparation May Lead to a Higher Feasibility of Intestinal Infection
Primary Purpose
Healthy
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
2L of polyethyleneglycol
inulin
probiotic combination product
Sponsored by
About this trial
This is an interventional prevention trial for Healthy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
polyethyleneglycol only
polyethyleneglycol puls Inulin
polyethyleneglycol puls probiotic combination product
Arm Description
participants take 2L of polyethyleneglycol only
participants take 2L of polyethyleneglycol, subsequently take 15g inulin per day.
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.
Outcomes
Primary Outcome Measures
Polyethyleneglycol could lead to changes in the intestinal flora
People with polyethyleneglycol administration will lead to a decrease of intestinal flora quantity
Secondary Outcome Measures
inulin and probiotics could improve the recovery of gut microbiota
inulin and probiotics will improve the recovery of flora quantity after Polyethyleneglycol administration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05277090
Brief Title
Bowel Preparation May Lead to a Higher Feasibility of Intestinal Infection
Official Title
Bowel Preparation for Colonoscopy May Lead to a Higher Feasibility of Intestinal Infection: a Clinical and Basic Research
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 15, 2022 (Anticipated)
Primary Completion Date
March 15, 2022 (Anticipated)
Study Completion Date
March 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yanqing Li
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
polyethyleneglycol only
Arm Type
Experimental
Arm Description
participants take 2L of polyethyleneglycol only
Arm Title
polyethyleneglycol puls Inulin
Arm Type
Experimental
Arm Description
participants take 2L of polyethyleneglycol, subsequently take 15g inulin per day.
Arm Title
polyethyleneglycol puls probiotic combination product
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
2L of polyethyleneglycol
Intervention Description
2L of polyethyleneglycol
Intervention Type
Dietary Supplement
Intervention Name(s)
inulin
Intervention Description
15g inulin per day
Intervention Type
Combination Product
Intervention Name(s)
probiotic combination product
Intervention Description
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 Measure Information:
Title
Polyethyleneglycol could lead to changes in the intestinal flora
Description
People with polyethyleneglycol administration will lead to a decrease of intestinal flora quantity
Time Frame
one year(from 15/3/2022 to 15/3/2023)
Secondary Outcome Measure Information:
Title
inulin and probiotics could improve the recovery of gut microbiota
Description
inulin and probiotics will improve the recovery of flora quantity after Polyethyleneglycol administration
Time Frame
one year(from 15/3/2022 to 15/3/2023)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guanjun Kou
Phone
18560086107
Email
kouguanjun88@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guanjun Kou
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bowel Preparation May Lead to a Higher Feasibility of Intestinal Infection
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