NCT04794049

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: First People's Hospital of Hangzhou · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Lactulose	In experiment cohort, patients do not use standard bowel preparation regimen, they totally drink 300ml lactulose.
DRUG	Polyethylene Glycol (PEG)	In control cohort, patients use the standard split-dose bowel preparation regimen,

Timeline

• Start date: 2021-05-01
• Primary completion: 2021-10-30
• Completion: 2021-12-31
• First posted: 2021-03-11
• Last updated: 2021-03-11