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

NCT05076799 | Completed Phase 3 DMC

• 1 other identifier: Sichuan U
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Polyethylene Glycols; Colonoscopy; Laxatives; Lactulose

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The colorectal diseases detection rate

  up to 12 months

• The adverse events

  up to 12 months

Study Arms (4)

3 L Polyethylene glycol solution group

ACTIVE COMPARATOR

The participants were instructed to consume 3000 mL of PEG solution

Drug: 3 L Polyethylene glycol solution

100 ml lactulose combined with 1 L PEG group

EXPERIMENTAL

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

100 ml lactulose combined with 2 L PEG group

EXPERIMENTAL

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

200 ml lactulose group

EXPERIMENTAL

the participants were instructed to consume 200 ml lactulose

Drug: 200 ml lactulose

Interventions

100 ml lactulose combined with 1 L PEG DRUG

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

Also known as: lactulose and 1 L PEG group

100 ml lactulose combined with 1 L PEG group

100 ml lactulose combined with 2 L PEG DRUG

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

Also known as: lactulose and 2 L PEG group

100 ml lactulose combined with 2 L PEG group

200 ml lactulose DRUG

the participants were instructed to consume 200 ml lactulose alone

Also known as: lactulose group

200 ml lactulose group

3 L Polyethylene glycol solution DRUG

the participants were instructed to consume 3000 mL of PEG solution

Also known as: control group, PEG group

3 L Polyethylene glycol solution group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sichuan University: lead
• Affiliated Hospital of Southwest Medical University: collaborator
• Affiliated Hospital of North Sichuan Medical College: collaborator

Study Sites (1)

west china fourth hospital of Sichuan university

Chengdu, Sichuan, 610014, China

Location

MeSH Terms

Interventions

Lactulose; Control Groups

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• juan liao, PhD

  West China Forth Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: October 13, 2021
• Study Start: September 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: January 3, 2023

Record last verified: 2022-12

Locations

CN (1)