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

NCT ID: NCT05076799

Last Updated: 2023-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-11-30

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.

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.

Conditions

Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

3 L Polyethylene glycol solution group

The participants were instructed to consume 3000 mL of PEG solution

Group Type: ACTIVE_COMPARATOR

3 L Polyethylene glycol solution

Intervention Type: DRUG

the participants were instructed to consume 3000 mL of PEG solution

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

Group Type: EXPERIMENTAL

100 ml lactulose combined with 1 L PEG

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

100 ml lactulose combined with 2 L PEG

Intervention Type: DRUG

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

200 ml lactulose group

the participants were instructed to consume 200 ml lactulose

Group Type: EXPERIMENTAL

200 ml lactulose

Intervention Type: DRUG

the participants were instructed to consume 200 ml lactulose alone

Interventions

100 ml lactulose combined with 1 L PEG

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

Intervention Type: 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

Intervention Type: DRUG

200 ml lactulose

the participants were instructed to consume 200 ml lactulose alone

Intervention Type: DRUG

3 L Polyethylene glycol solution

the participants were instructed to consume 3000 mL of PEG solution

Intervention Type: DRUG

Other Intervention Names

lactulose and 1 L PEG group; lactulose and 2 L PEG group; lactulose group; control group; PEG group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Affiliated Hospital of Southwest Medical University

OTHER

Sponsor Role: collaborator

Affiliated Hospital of North Sichuan Medical College

OTHER

Sponsor Role: collaborator

Sichuan University

OTHER

Sponsor Role: lead

Responsible Party

Lin Cai

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

juan liao, PhD

Role: STUDY_DIRECTOR

West China Forth Hospital

Locations

west china fourth hospital of Sichuan university

Chengdu, Sichuan, China

Countries

China

Other Identifiers

Sichuan U

Identifier Type: -

Identifier Source: org_study_id