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

IBD Clinical Trial

Official title:

Evaluate Lactulose for Bowel Preparation in Patients With Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05878639
• Other study ID #: SAHoWMU-CR2023-01-104
• Status: Completed
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: July 1, 2023

Study information

• Verified date: July 2023
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• IBD
• Inflammatory Bowel Diseases

Intervention

Drug:
• 3 bottles of Lactulose oral solution
Patients will take lactulose for bowel preparation.
• 3L-polyethylene glycol
Patients will take 3L-polyethylene glycol for bowel preparation.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effective preparation rate	Boston Bowel Preparation Scale (BBPS) >= 6 with a partial score >= 2 in each colon segment	5 minutes before the colonoscopy ends
Primary	incidence of adverse events	incidence of adverse events in each group	2 hours after having bowel preparation
Primary	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	effects of bowel preparation drugs on liver function	total protein, albumin, bilirubin, alanine aminotransferase	2 hours after having bowel preparation
Secondary	effects of bowel preparation drugs on serum electrolyte	sodium, potassium, chloride	2 hours after having bowel preparation