Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation

Sponsor

First People's Hospital of Hangzhou (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04794049

Collaborator

(none)

800

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Disease	Drug: Lactulose Drug: Polyethylene Glycol (PEG)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Screening

Official Title:

Oral Lactulose is Not Inferior to The Standard Bowel Preparation Regimen for Bowel Preparation Prior Colonoscopy

Anticipated Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

Oct 30, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experiment cohort 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.	Drug: Lactulose In experiment cohort, patients do not use standard bowel preparation regimen, they totally drink 300ml lactulose.
Active Comparator: Control cohort 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.	Drug: Polyethylene Glycol (PEG) In control cohort, patients use the standard split-dose bowel preparation regimen,

Arm

Intervention/Treatment

Experimental: Experiment cohort

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.

Drug: Lactulose

In experiment cohort, patients do not use standard bowel preparation regimen, they totally drink 300ml lactulose.

Active Comparator: Control cohort

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.

Drug: Polyethylene Glycol (PEG)

In control cohort, patients use the standard split-dose bowel preparation regimen,

Outcome Measures

Primary Outcome Measures

Bowel preparation [2 hours]
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 [2 hours]
Willingness to repeat bowel preparation (BP) [2 hours]
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 [2 hours]
Insertion time [2 hours]
Withdrawal time [2 hours]
Cecal intubation rate [2 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

First People's Hospital of Hangzhou

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ZhangXiaofeng, Director of Department of Gastroenterology, First People's Hospital of Hangzhou

ClinicalTrials.gov Identifier:

NCT04794049

Other Study ID Numbers:

074-1

First Posted:

Mar 11, 2021

Last Update Posted:

Mar 11, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by ZhangXiaofeng, Director of Department of Gastroenterology, First People's Hospital of Hangzhou

colonoscopy

bowel preparation

Additional relevant MeSH terms:

Colonic Diseases

Lactulose

Study Results

No Results Posted as of Mar 11, 2021