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NCT Number: NCT05076799

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

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.

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Key information

Conditions

Colonoscopy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

west china fourth hospital of Sichuan university

Chengdu, Sichuan, 610014, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: lactulose and 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

Other names: lactulose and 2 L PEG group

200 ml lactulose

Drug

the participants were instructed to consume 200 ml lactulose alone

Other names: lactulose group

3 L Polyethylene glycol solution

Drug

the participants were instructed to consume 3000 mL of PEG solution

Other names: control group, PEG group

Primary outcomes

  1. The quality of bowel preparation

    Time frame: up to 12 months

    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.

  2. The preparation intolerance

    Time frame: up to 12 months

    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.

Secondary outcomes

  1. The colorectal diseases detection rate

    Time frame: up to 12 months

    the cecal intubation time, colonoscopy perform time, and polyp detection rate or colorectal cancer detection rate are recorded.

  2. The adverse events

    Time frame: up to 12 months

    the adverse events including nausea, vomiting, abdominal pain, abdominal distension, and other adverse reactions after administration are evaluated.

Sponsors and collaborators

Lead sponsor

Sichuan University

Other

Collaborators

  • Affiliated Hospital of Southwest Medical University
  • Affiliated Hospital of North Sichuan Medical College

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 13, 2021
Registry last updated
Jan 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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