drugset / Trial / NCT05878639

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

NCT05878639

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2023-03-28
Primary completion
2023-07-01
Completion
2023-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Lactulose Other / unclassified Oral
Comparator polyethylene glycol Other / unclassified 3000 ml Oral