Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation

Zhejiang University

Status: Unknown

Conditions: Colon Disease

Treatments: Drug: Lactulose; Drug: Polyethylene Glycol (PEG)

Study type: Interventional

Funder types: Other

Identifiers

NCT04794049

074-1

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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800 participants in 2 patient groups

Experiment cohort

Experimental group

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.

Treatment:

Drug: Lactulose

Control cohort

Active Comparator group

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.

Treatment:

Drug: Polyethylene Glycol (PEG)