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

Effect of Lactulose and/ or Polyethylene Glycol Solution for Bowel Preparation in Colonscopy: a Multi-center Prospective Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: 3 L Polyethylene glycol solution; Drug: 100 ml lactulose combined with 1 L PEG; Drug: 100 ml lactulose combined with 2 L PEG; Drug: 200 ml lactulose

Detailed Description

This study will conduct in 5 clinical central. 1000 participants who were scheduled for colonoscopy age between 18 and 80 years were enrolled in the study. Exclusion criteria were patients with uncontrolled acute or recurrent chronic intestinal infections, with active gastrointestinal bleeding or gastrointestinal stricture or intestinal obstruction, with severity coronary heart disease or heart failure or renal failure and liver failure or severe electrolyte metabolism disorder, with pregnant or lactating or metal diseases or refuse to colonoscopy examination. Central stratification and block randomization is achieved via a computer-generated random-sequence table by using R software. The participants will be assigned into one of four groups at a ratio of 1 : 1, and received a single 3 L dose of either PEG or 200ml dose of lactulose, 100ml lactulose combined with 1L PEG, 100ml lactulose combined with 2L PEG. The following parameters were then obtained: time of the first defecation, defecation frequency, the overall drink liquid volume, the taste of the preparation, the tolerance evaluation, the cleansing quality of the bowel preparations and adverse reaction.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chendu, Sichuan, China, 610014
      • West China Fourth Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants who were scheduled for colonoscopy age between 18 and 80 years

Exclusion Criteria:

• uncontrolled acute or recurrent chronic intestinal infections
• active gastrointestinal bleeding, gastrointestinal stricture, intestinal obstruction
• severe electrolyte metabolism disorder, severe coronary heart disease, heart failure, renal failure or liver failure
• pregnant, lactating, have metal diseases or refuse to colonoscopy examination

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 3 L Polyethylene glycol solution group; The participants were instructed to consume 3000 mL of PEG solution	Drug: 3 L Polyethylene glycol solution; the participants were instructed to consume 3000 mL of PEG solution; Other Names: control group; PEG group
Experimental: 100 ml lactulose combined with 1 L PEG group; the participants were instructed to consume 100 ml lactulose combined with 1000 mL of PEG solution	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; Other Names: lactulose and 1 L PEG group
Experimental: 100 ml lactulose combined with 2 L PEG group; the participants were instructed to consume 100 ml lactulose combined with 2000 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; Other Names: lactulose and 2 L PEG group
Experimental: 200 ml lactulose group; the participants were instructed to consume 200 ml lactulose	Drug: 200 ml lactulose; the participants were instructed to consume 200 ml lactulose alone; Other Names: lactulose group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The quality of bowel preparation	to assess the quality of bowel preparation by using Boston Bowel Preparation Scale. The minimum score value is 0，and the maximum value is 9. A higher score means a better outcome. Bowel cleansing was scored by the endoscopist performing the colonoscopy in the single-blind method.	up to 12 months
The preparation intolerance	to assess the preparation intolerance including the palatability of the bowel-cleansing agents, the general satisfaction with the bowel preparation, the willingness to perform another colonoscopy by using case report questionnaire. Moreover, the ratio of drink all preparation fluids and the specific amount of bowel preparation fluid are documented.	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The colorectal diseases detection rate	the cecal intubation time, colonoscopy perform time, and polyp detection rate or colorectal cancer detection rate are recorded.	up to 12 months
The adverse events	the adverse events including nausea, vomiting, abdominal pain, abdominal distension, and other adverse reactions after administration are evaluated.	up to 12 months

Collaborators and Investigators

• Sponsor: Sichuan University
• Collaborators: Affiliated Hospital of North Sichuan Medical College; Affiliated Hospital of Southwest Medical University
• Investigators: Study Director: juan liao, PhD, West China Forth Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 13, 2021

Study Record Updates

• Last Update Posted (Estimate): January 2, 2023
• Last Update Submitted That Met QC Criteria: December 29, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Colonoscopy; Polyethylene Glycols; Lactulose; Laxatives
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Lactulose
• Other Study ID Numbers: Sichuan U

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No