Clinical trial NCT05878639: Efficacy and Safety of Lactulose for Bowel Preparation in Patients With Inflammatory Bowel Disease
Official title: Evaluate Lactulose for Bowel Preparation in Patients With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IBD
Keywords: colonoscopy
polyethylene glycol
IBD
bowel preparation
lactulose
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 140
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* All patients with confirmed IBD or suspected IBD for at least 3 months, aged between 16-75 years and requiring a colonoscopy are invited to participate in our study. The diagnosis of IBD is based on recognized standards, including clinical symptoms, endoscopy, radiology, pathology and surgical history.

Exclusion Criteria:

* Patients are excluded if they (1) are clinical active UC and CD, (2) are known or suspected gastrointestinal obstruction, bowel perforation, toxic colitis or megacolon, recent or active gastrointestinal bleeding, (3) are congestive heart failure, severe renal failure, (4) are severe dehydration or electrolyte disturbances, (5) are pregnant, (6) are allergic to PEG or Lactulose, (7) are diabetics, (8) are lactose or galactose intolerance, (9) refuse to participate in this study.

Primary outcomes:
measure: effective preparation rate
timeFrame: 5 minutes before the colonoscopy ends
measure: incidence of adverse events
timeFrame: 2 hours after having bowel preparation
measure: taste score evaluated by patients
timeFrame: 2 hours after having bowel preparation
Secondary outcomes:
measure: effects of bowel preparation drugs on liver function
timeFrame: 2 hours after having bowel preparation
measure: effects of bowel preparation drugs on serum electrolyte
timeFrame: 2 hours after having bowel preparation
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Department of Gastroenterology, The Second Affiliated Hospital of Wenzhou Medical University
name: Lin Daopo
role: STUDY_DIRECTOR
References: