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Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation

Primary Purpose

Colon Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lactulose
Polyethylene Glycol (PEG)
Sponsored by
First People's Hospital of Hangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colon Disease focused on measuring colonoscopy, bowel preparation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age 18-80 patients with intact colon and rectum

Exclusion Criteria:

  • prior finding of severe colorectal stricture
  • without the requirement of reaching cecum
  • suspected colonic stricture or perforation
  • use of prokinetic agents or purgatives within 7 days
  • toxic colitis or megacolon
  • pregnant women
  • hemodynamically unstable
  • patients who cannot give informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experiment cohort

    Control cohort

    Arm Description

    4-6 hours before colonoscopy, patients in experiment cohort began to drink the first 150ml lactulose and half hour later, drink other 150ml lactulose dissolved in 1.5 L of water at a rate of 250ml every 15 minutes.

    The participants in control cohort began to drink the first 2 L of PEG at 7:00-9 PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients took the remaining 2 L 4-6 hours before colonoscopy.

    Outcomes

    Primary Outcome Measures

    Bowel preparation
    Boston bowel preparation score (BBPS):cleanliness of each part of the colon: 0=unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1=portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid; 2=minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3=entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid.

    Secondary Outcome Measures

    Adverse events
    Willingness to repeat bowel preparation (BP)
    We will ask patients in the form of questionnaire whether they are willing to repeat the same bowel preparation method if they need colonoscopy examination again.
    Adenoma detection rate
    Insertion time
    Withdrawal time
    Cecal intubation rate

    Full Information

    First Posted
    January 30, 2021
    Last Updated
    March 10, 2021
    Sponsor
    First People's Hospital of Hangzhou
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04794049
    Brief Title
    Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation
    Official Title
    Oral Lactulose is Not Inferior to The Standard Bowel Preparation Regimen for Bowel Preparation Prior Colonoscopy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2021 (Anticipated)
    Primary Completion Date
    October 30, 2021 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    First People's Hospital of Hangzhou

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Adequate quality of bowel preparation(BP) is essential for colonoscopy. Several guidelines recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the high-volume PEG caused lower compliance to the regime and increased cost. Oral lactulose is a treatment for constipation. It tastes sweet and has no obvious gastrointestinal side effects. Previous study shows 200ml lactulose oral solution plus 2L water has been proven superior BP compared to 2L PEG. However, there is a lack of research describing bowel cleansing and colonoscopy outcomes using lactulose oral solution compared with the standard split dose of 4L PEG. Here we compared the use of a lactulose oral solution (300ml+1.5 L) with a PEG formulation (2 L) for colonoscopy preparation using the following metrics: quality of cleansing, colonoscopy outcomes, patient/physician satisfaction, and patient tolerability.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colon Disease
    Keywords
    colonoscopy, bowel preparation

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    800 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experiment cohort
    Arm Type
    Experimental
    Arm Description
    4-6 hours before colonoscopy, patients in experiment cohort began to drink the first 150ml lactulose and half hour later, drink other 150ml lactulose dissolved in 1.5 L of water at a rate of 250ml every 15 minutes.
    Arm Title
    Control cohort
    Arm Type
    Active Comparator
    Arm Description
    The participants in control cohort began to drink the first 2 L of PEG at 7:00-9 PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients took the remaining 2 L 4-6 hours before colonoscopy.
    Intervention Type
    Drug
    Intervention Name(s)
    Lactulose
    Intervention Description
    In experiment cohort, patients do not use standard bowel preparation regimen, they totally drink 300ml lactulose.
    Intervention Type
    Drug
    Intervention Name(s)
    Polyethylene Glycol (PEG)
    Intervention Description
    In control cohort, patients use the standard split-dose bowel preparation regimen,
    Primary Outcome Measure Information:
    Title
    Bowel preparation
    Description
    Boston bowel preparation score (BBPS):cleanliness of each part of the colon: 0=unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1=portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid; 2=minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3=entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid.
    Time Frame
    2 hours
    Secondary Outcome Measure Information:
    Title
    Adverse events
    Time Frame
    2 hours
    Title
    Willingness to repeat bowel preparation (BP)
    Description
    We will ask patients in the form of questionnaire whether they are willing to repeat the same bowel preparation method if they need colonoscopy examination again.
    Time Frame
    2 hours
    Title
    Adenoma detection rate
    Time Frame
    2 hours
    Title
    Insertion time
    Time Frame
    2 hours
    Title
    Withdrawal time
    Time Frame
    2 hours
    Title
    Cecal intubation rate
    Time Frame
    2 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age 18-80 patients with intact colon and rectum Exclusion Criteria: prior finding of severe colorectal stricture without the requirement of reaching cecum suspected colonic stricture or perforation use of prokinetic agents or purgatives within 7 days toxic colitis or megacolon pregnant women hemodynamically unstable patients who cannot give informed consent
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hui Jia, MD
    Phone
    86-0571-56006821
    Email
    JIAHUIFMMU@163.COM

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

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    Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation

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