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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
Yanqing Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 19, 2021
    Last Updated
    March 2, 2022
    Sponsor
    Yanqing Li
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    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

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    Bowel Preparation May Lead to a Higher Feasibility of Intestinal Infection

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