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

Sichuan University

Status and phase: Completed; Phase 3

Conditions: Colonoscopy

Treatments: Drug: 3 L Polyethylene glycol solution; Drug: 100 ml lactulose combined with 2 L PEG; Drug: 100 ml lactulose combined with 1 L PEG; Drug: 200 ml lactulose

Study type: Interventional

Funder types: Other

Identifiers

NCT05076799

Sichuan U

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups

3 L Polyethylene glycol solution group

Active Comparator group

Description:

The participants were instructed to consume 3000 mL of PEG solution

Treatment:

Drug: 3 L Polyethylene glycol solution

100 ml lactulose combined with 1 L PEG group

Experimental group

Description:

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

Treatment:

Drug: 100 ml lactulose combined with 1 L PEG

100 ml lactulose combined with 2 L PEG group

Experimental group

Description:

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

Treatment:

Drug: 100 ml lactulose combined with 2 L PEG

200 ml lactulose group

Experimental group

Description:

the participants were instructed to consume 200 ml lactulose

Treatment:

Drug: 200 ml lactulose