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
Drug: 2L of polyethyleneglycol
2L of polyethyleneglycol
Experimental: polyethyleneglycol puls Inulin
participants take 2L of polyethyleneglycol, subsequently take 15g inulin per day.
Drug: 2L of polyethyleneglycol
2L of polyethyleneglycol
Dietary supplement: inulin
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.
Drug: 2L of polyethyleneglycol
2L of polyethyleneglycol
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.

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

Yanqing Li

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.

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