Bowel Preparation May Lead to a Higher Feasibility of Intestinal Infection
Bowel Preparation for Colonoscopy May Lead to a Higher Feasibility of Intestinal Infection: a Clinical and Basic Research
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1 healthy
Started Mar 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2021
CompletedFirst Posted
Study publicly available on registry
March 14, 2022
CompletedStudy Start
First participant enrolled
March 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2022
CompletedMarch 14, 2022
March 1, 2022
Same day
October 19, 2021
March 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
inulin and probiotics could improve the recovery of gut microbiota
one year(from 15/3/2022 to 15/3/2023)
Study Arms (3)
polyethyleneglycol only
EXPERIMENTALparticipants take 2L of polyethyleneglycol only
polyethyleneglycol puls Inulin
EXPERIMENTALparticipants take 2L of polyethyleneglycol, subsequently take 15g inulin per day.
polyethyleneglycol puls probiotic combination product
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- patients who agree to participant in the study
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yanqing Lilead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guanjun Kou
Qilu Hospital of Shandong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 19, 2021
First Posted
March 14, 2022
Study Start
March 15, 2022
Primary Completion
March 15, 2022
Study Completion
March 15, 2022
Last Updated
March 14, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share