Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation

Colon Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04794049
• Other study ID #: 074-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: First People's Hospital of Hangzhou
• Contact: Hui Jia, MD
• Phone: 86-0571-56006821
• Email: JIAHUIFMMU[@]163.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: December 31, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Disease
• Colonic Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse events		2 hours
Secondary	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
Secondary	Adenoma detection rate		2 hours
Secondary	Insertion time		2 hours
Secondary	Withdrawal time		2 hours
Secondary	Cecal intubation rate		2 hours