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Effect of Lactulose and/or Polyethylene Glycol Solution for Bowel Preparation for Colonscopy Procedures

NCT05076799 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-01-03

No results posted yet for this study

Summary

Colonoscopy is the most useful exam used to evaluate colorectal diseases, like colorectal polyps and cancer. The appropriate bowel preparation is indispensable for colonoscopy procedures. Polyethylene glycol solution (PEG) is the most frequent laxative medication. However, the taste is poor, and patients need to drink a lot of liquids to obtain adequate visualization of the mucosal surface. In fact, no laxative has all the characteristics of an ideal medication. Lactulose is an osmotic laxative which widely used in cirrhosis and constipation patients, and could inhibit bacterial in the colon to increase colon cleanliness and prolong the effect time of PEG. Previous study demonstrate PEG combined with lactulose has a significant improvement in the quality of bowel preparation compared with PEG alone. The present study aim to assess the efficacy of lactulose with or without PEG in bowel preparation to improve mucosal visualization, reduced volume of fluid consumed, and preparation intolerance.

Conditions

  • Colonoscopy

Interventions

DRUG

100 ml lactulose combined with 1 L PEG

the participants were instructed to consume 100 ml lactulose combined with 1000 mL of PEG solution

DRUG

100 ml lactulose combined with 2 L PEG

the participants were instructed to consume 100 ml lactulose combined with 2000 mL of PEG solution

DRUG

200 ml lactulose

the participants were instructed to consume 200 ml lactulose alone

DRUG

3 L Polyethylene glycol solution

the participants were instructed to consume 3000 mL of PEG solution

Sponsors & Collaborators

  • Affiliated Hospital of Southwest Medical University

    collaborator OTHER

  • Affiliated Hospital of North Sichuan Medical College

    collaborator OTHER

  • Sichuan University

    lead OTHER

Principal Investigators

  • juan liao, PhD · West China Forth Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05076799 on ClinicalTrials.gov