NCT05878639

Efficacy and Safety of Lactulose for Bowel Preparation in Patients With Inflammatory Bowel Disease

Evaluate Lactulose for Bowel Preparation in Patients With Inflammatory Bowel Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the efficacy, safety and tolerability of lactulose in bowel preparation in IBD patients. The main question it aims to answer is: Does lactulose have better efficacy, safety and tolerability than 3L-PEG? Participants will be divided into PEG group or Lactulose group at a 1:1 ratio by a random number method. Each patient will get a leaflet provided by hospital introducing bowel preparation methods and diet restriction before bowel preparation. They will have bowel preparation with different drugs according to group. The grade of bowel cleansing will be assessed through the Boston Bowel Preparation Scale (BBPS). The tolerability, satisfaction and safety of the two bowel preparation methods will be assessed through the patients self-administered questionnaires.

Conditions

• IBD

Interventions

Type	Name	Description
DRUG	3 bottles of Lactulose oral solution	Patients will take lactulose for bowel preparation.
DRUG	3L-polyethylene glycol	Patients will take 3L-polyethylene glycol for bowel preparation.

Timeline

• Start date: 2023-03-28
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2023-05-26
• Last updated: 2023-08-01

Locations

1 site across 1 country: China