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Completed

NCT Number: NCT05878639

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

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.

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Key information

Conditions

IBD

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3 bottles of Lactulose oral solution

Drug

Patients will take lactulose for bowel preparation.

3L-polyethylene glycol

Drug

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

Primary outcomes

  1. effective preparation rate

    Time frame: 5 minutes before the colonoscopy ends

    Boston Bowel Preparation Scale (BBPS) >= 6 with a partial score >= 2 in each colon segment

  2. incidence of adverse events

    Time frame: 2 hours after having bowel preparation

    incidence of adverse events in each group

  3. taste score evaluated by patients

    Time frame: 2 hours after having bowel preparation

    Five-point scale is used to evaluate taste (very bad, bad, moderate, good, very good)

Secondary outcomes

  1. effects of bowel preparation drugs on liver function

    Time frame: 2 hours after having bowel preparation

    total protein, albumin, bilirubin, alanine aminotransferase

  2. effects of bowel preparation drugs on serum electrolyte

    Time frame: 2 hours after having bowel preparation

    sodium, potassium, chloride

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

Evaluate Lactulose for Bowel Preparation in Patients With Inflammatory Bowel Disease

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 26, 2023
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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