Efficacy and Safety of Lactulose for Bowel Preparation in Patients With Inflammatory Bowel Disease
NCT05878639 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2023-08-01
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
Interventions
- 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.
Sponsors & Collaborators
-
Second Affiliated Hospital of Wenzhou Medical University
lead OTHER
Principal Investigators
-
Lin Daopo · Department of Gastroenterology, The Second Affiliated Hospital of Wenzhou Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-28
- Primary Completion
- 2023-07-01
- Completion
- 2023-07-01
Countries
- China
Study Locations
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