Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colon Disease
• Intervention / Treatment: Drug: Lactulose; Drug: Polyethylene Glycol (PEG)

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hui Jia, MD; Phone Number: 86-0571-56006821; Email: JIAHUIFMMU@163.COM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events		2 hours
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.	2 hours
Adenoma detection rate		2 hours
Insertion time		2 hours
Withdrawal time		2 hours
Cecal intubation rate		2 hours

Collaborators and Investigators

• Sponsor: First People's Hospital of Hangzhou

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): October 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: January 30, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: colonoscopy; bowel preparation
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Colonic Diseases; Gastrointestinal Agents; Lactulose
• Other Study ID Numbers: 074-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No