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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluate Lactulose for Bowel Preparation in Patients With Inflammatory Bowel Disease

Conditions
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IBD

Intervention / Treatment
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* Drug: 3 bottles of Lactulose oral solution
* Drug: 3L-polyethylene glycol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients take Lactulose for bowel preparation<br>Patients take Lactulose for bowel preparation. | Drug: 3 bottles of Lactulose oral solution<br>* Patients will take lactulose for bowel preparation.<br>|
| Active Comparator: Patients take 3L-polyethylene glycol for bowel preparation<br>Patients take 3L-polyethylene glycol for bowel preparation . | Drug: 3L-polyethylene glycol<br>* Patients will take 3L-polyethylene glycol for bowel preparation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effective preparation rate | Boston Bowel Preparation Scale (BBPS) >= 6 with a partial score >= 2 in each colon segment | 5 minutes before the colonoscopy ends | 
| incidence of adverse events | incidence of adverse events in each group | 2 hours after having bowel preparation | 
| taste score evaluated by patients | Five-point scale is used to evaluate taste (very bad, bad, moderate, good, very good) | 2 hours after having bowel preparation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effects of bowel preparation drugs on liver function | total protein, albumin, bilirubin, alanine aminotransferase | 2 hours after having bowel preparation | 
| effects of bowel preparation drugs on serum electrolyte | sodium, potassium, chloride | 2 hours after having bowel preparation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, polyethylene glycol, IBD, bowel preparation, lactulose