Clinical trial NCT05076799: Effect of Lactulose and/or Polyethylene Glycol Solution for Bowel Preparation for Colonscopy Procedures
Official title: Effect of Lactulose and/ or Polyethylene Glycol Solution for Bowel Preparation in Colonscopy: a Multi-center Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colonoscopy
Keywords: Polyethylene Glycols
Colonoscopy
Laxatives
Lactulose
Lead sponsor: Sichuan University
Sponsor class: OTHER
Collaborators: name: Affiliated Hospital of Southwest Medical University
name: Afﬁliated Hospital of North Sichuan Medical College
First posted: 2021-10-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: The quality of bowel preparation
timeFrame: up to 12 months
measure: The preparation intolerance
timeFrame: up to 12 months
Secondary outcomes:
measure: The colorectal diseases detection rate
timeFrame: up to 12 months
measure: The adverse events
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Chendu
country: China
facility: west china fourth hospital of Sichuan university
state: Sichuan
Study officials:
affiliation: West China Forth Hospital
name: juan liao, PhD
role: STUDY_DIRECTOR
References: