IBD
Conditions
Keywords
colonoscopy, polyethylene glycol, IBD, bowel preparation, lactulose
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.
Interventions
DRUG3 bottles of Lactulose oral solution
Patients will take lactulose for bowel preparation.
DRUG3L-polyethylene glycol
Patients will take 3L-polyethylene glycol for bowel preparation.
Sponsors
Second Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| effective preparation rate | 5 minutes before the colonoscopy ends | Boston Bowel Preparation Scale (BBPS) \>= 6 with a partial score \>= 2 in each colon segment |
| incidence of adverse events | 2 hours after having bowel preparation | incidence of adverse events in each group |
| taste score evaluated by patients | 2 hours after having bowel preparation | Five-point scale is used to evaluate taste (very bad, bad, moderate, good, very good) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| effects of bowel preparation drugs on liver function | 2 hours after having bowel preparation | total protein, albumin, bilirubin, alanine aminotransferase |
| effects of bowel preparation drugs on serum electrolyte | 2 hours after having bowel preparation | sodium, potassium, chloride |
Countries
China
Outcome results
None listed