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

Sponsor

Second Affiliated Hospital of Wenzhou Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05878639

Collaborator

(none)

140

Enrollment

Location

Arms

2.8

Anticipated Duration (Months)

50.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
IBD	Drug: 3 bottles of Lactulose oral solution Drug: 3L-polyethylene glycol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Evaluate Lactulose for Bowel Preparation in Patients With Inflammatory Bowel Disease

Actual Study Start Date :

Mar 28, 2023

Anticipated Primary Completion Date :

May 20, 2023

Anticipated Study Completion Date :

Jun 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients take Lactulose for bowel preparation Patients take Lactulose for bowel preparation.	Drug: 3 bottles of Lactulose oral solution Patients will take lactulose for bowel preparation.
Active Comparator: Patients take 3L-polyethylene glycol for bowel preparation Patients take 3L-polyethylene glycol for bowel preparation .	Drug: 3L-polyethylene glycol Patients will take 3L-polyethylene glycol for bowel preparation.

Arm

Intervention/Treatment

Experimental: Patients take Lactulose for bowel preparation

Patients take Lactulose for bowel preparation.

Drug: 3 bottles of Lactulose oral solution

Patients will take lactulose for bowel preparation.

Active Comparator: Patients take 3L-polyethylene glycol for bowel preparation

Patients take 3L-polyethylene glycol for bowel preparation .

Drug: 3L-polyethylene glycol

Patients will take 3L-polyethylene glycol for bowel preparation.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.