Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation

NCT ID: NCT04794049

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2021-12-31

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.

Conditions

Colon Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lactulose

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Polyethylene Glycol (PEG)

Intervention Type: DRUG

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

Interventions

Lactulose

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

Intervention Type: DRUG

Polyethylene Glycol (PEG)

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First People's Hospital of Hangzhou

OTHER

Sponsor Role: lead

Responsible Party

ZhangXiaofeng

Director of Department of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hui Jia, MD

Role: CONTACT

JIAHUIFMMU@163.COM

86-0571-56006821

Other Identifiers

074-1

Identifier Type: -

Identifier Source: org_study_id