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

NCT05878639 | Completed

• 1 other identifier: SAHoWMU-CR2023-01-104
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

IBD

Keywords

colonoscopy; polyethylene glycol; IBD; bowel preparation; lactulose

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• effects of bowel preparation drugs on liver function

  2 hours after having bowel preparation

• effects of bowel preparation drugs on serum electrolyte

  2 hours after having bowel preparation

Study Arms (2)

Patients take Lactulose for bowel preparation

EXPERIMENTAL

Patients take Lactulose for bowel preparation.

Drug: 3 bottles of Lactulose oral solution

Patients take 3L-polyethylene glycol for bowel preparation

ACTIVE COMPARATOR

Patients take 3L-polyethylene glycol for bowel preparation .

Drug: 3L-polyethylene glycol

Interventions

3 bottles of Lactulose oral solution DRUG

Patients will take lactulose for bowel preparation.

Patients take Lactulose for bowel preparation

3L-polyethylene glycol DRUG

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

Patients take 3L-polyethylene glycol for bowel preparation

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Interventions

Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Lin Daopo

  Department of Gastroenterology, The Second Affiliated Hospital of Wenzhou Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 26, 2023
• Study Start: March 28, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)