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
About this trial
This is an interventional screening trial for Colon Disease focused on measuring colonoscopy, bowel preparation
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
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
NCT ID
NCT04794049
First Posted
January 30, 2021
Last Updated
March 10, 2021
Sponsor
First People's Hospital of Hangzhou
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
Learn more about this trial
Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation
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