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

Not Applicable

Completed

• Conditions: IBD
• Interventions: Drug: 3 bottles of Lactulose oral solution; Drug: 3L-polyethylene glycol

• Registration Number: NCT05878639
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-28
• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-18
• Study First Posted: 2023-05-26
• Status Verified: 2023-07
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients take Lactulose for bowel preparation	3 bottles of Lactulose oral solution	Patients take Lactulose for bowel preparation.
Patients take 3L-polyethylene glycol for bowel preparation	3L-polyethylene glycol	Patients take 3L-polyethylene glycol for bowel preparation .

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Second Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China