Back to resultsEfficacy and Safety of Lactulose for Bowel Preparation in Patients With Inflammatory Bowel Disease
Primary Purpose
IBD
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
3 bottles of Lactulose oral solution
3L-polyethylene glycol
Sponsored by
About this trial
This is an interventional treatment trial for IBD focused on measuring colonoscopy, polyethylene glycol, IBD, bowel preparation, lactulose
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.
Sites / Locations
- The Second Affiliated Hospital of Wenzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients take Lactulose for bowel preparation
Patients take 3L-polyethylene glycol for bowel preparation
Arm Description
Patients take Lactulose for bowel preparation.
Patients take 3L-polyethylene glycol for bowel preparation .
Outcomes
Primary Outcome Measures
effective preparation rate
Boston Bowel Preparation Scale (BBPS) >= 6 with a partial score >= 2 in each colon segment
incidence of adverse events
incidence of adverse events in each group
taste score evaluated by patients
Five-point scale is used to evaluate taste (very bad, bad, moderate, good, very good)
Secondary Outcome Measures
effects of bowel preparation drugs on liver function
total protein, albumin, bilirubin, alanine aminotransferase
effects of bowel preparation drugs on serum electrolyte
sodium, potassium, chloride
Full Information
NCT ID
NCT05878639
First Posted
May 10, 2023
Last Updated
July 31, 2023
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05878639
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 28, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Wenzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBD
Keywords
colonoscopy, polyethylene glycol, IBD, bowel preparation, lactulose
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients take Lactulose for bowel preparation
Arm Type
Experimental
Arm Description
Patients take Lactulose for bowel preparation.
Arm Title
Patients take 3L-polyethylene glycol for bowel preparation
Arm Type
Active Comparator
Arm Description
Patients take 3L-polyethylene glycol for bowel preparation
.
Intervention Type
Drug
Intervention Name(s)
3 bottles of Lactulose oral solution
Intervention Description
Patients will take lactulose for bowel preparation.
Intervention Type
Drug
Intervention Name(s)
3L-polyethylene glycol
Intervention Description
Patients will take 3L-polyethylene glycol for bowel preparation.
Primary Outcome Measure Information:
Title
effective preparation rate
Description
Boston Bowel Preparation Scale (BBPS) >= 6 with a partial score >= 2 in each colon segment
Time Frame
5 minutes before the colonoscopy ends
Title
incidence of adverse events
Description
incidence of adverse events in each group
Time Frame
2 hours after having bowel preparation
Title
taste score evaluated by patients
Description
Five-point scale is used to evaluate taste (very bad, bad, moderate, good, very good)
Time Frame
2 hours after having bowel preparation
Secondary Outcome Measure Information:
Title
effects of bowel preparation drugs on liver function
Description
total protein, albumin, bilirubin, alanine aminotransferase
Time Frame
2 hours after having bowel preparation
Title
effects of bowel preparation drugs on serum electrolyte
Description
sodium, potassium, chloride
Time Frame
2 hours after having bowel preparation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Daopo
Organizational Affiliation
Department of Gastroenterology, The Second Affiliated Hospital of Wenzhou Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The Second Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Lactulose for Bowel Preparation in Patients With Inflammatory Bowel Disease
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