NCT04794049

Brief Summary

Adequate quality of bowel preparation(BP) is essential for colonoscopy. Several guidelines recommend that split-dose of 4L PEG should be used as a standard regime for BP. However, the high-volume PEG caused lower compliance to the regime and increased cost. Oral lactulose is a treatment for constipation. It tastes sweet and has no obvious gastrointestinal side effects. Previous study shows 200ml lactulose oral solution plus 2L water has been proven superior BP compared to 2L PEG. However, there is a lack of research describing bowel cleansing and colonoscopy outcomes using lactulose oral solution compared with the standard split dose of 4L PEG. Here we compared the use of a lactulose oral solution (300ml+1.5 L) with a PEG formulation (2 L) for colonoscopy preparation using the following metrics: quality of cleansing, colonoscopy outcomes, patient/physician satisfaction, and patient tolerability.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

January 30, 2021

Last Update Submit

March 10, 2021

Conditions

Colon Disease

Keywords

colonoscopybowel preparation

Outcome Measures

Primary Outcomes (1)

  • Bowel preparation

    Boston bowel preparation score (BBPS)：cleanliness of each part of the colon: 0=unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared; 1=portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen because of staining, residual stool, and/or opaque liquid; 2=minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3=entire mucosa of colon segment seen well with no residual staining, small fragments of stool, or opaque liquid.

    2 hours

Secondary Outcomes (6)

  • Adverse events

    2 hours

  • Willingness to repeat bowel preparation (BP)

    2 hours

  • Adenoma detection rate

    2 hours

  • Insertion time

    2 hours

  • Withdrawal time

    2 hours

  • +1 more secondary outcomes

Study Arms (2)

Experiment cohort

EXPERIMENTAL

4-6 hours before colonoscopy, patients in experiment cohort began to drink the first 150ml lactulose and half hour later, drink other 150ml lactulose dissolved in 1.5 L of water at a rate of 250ml every 15 minutes.

Drug: Lactulose

Control cohort

ACTIVE COMPARATOR

The participants in control cohort began to drink the first 2 L of PEG at 7:00-9 PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients took the remaining 2 L 4-6 hours before colonoscopy.

Drug: Polyethylene Glycol (PEG)

Interventions

LactuloseDRUG

In experiment cohort, patients do not use standard bowel preparation regimen, they totally drink 300ml lactulose.

Experiment cohort
Polyethylene Glycol (PEG)DRUG

In control cohort, patients use the standard split-dose bowel preparation regimen,

Control cohort

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18-80 patients with intact colon and rectum

You may not qualify if:

  • prior finding of severe colorectal stricture
  • without the requirement of reaching cecum
  • suspected colonic stricture or perforation
  • use of prokinetic agents or purgatives within 7 days
  • toxic colitis or megacolon
  • pregnant women
  • hemodynamically unstable
  • patients who cannot give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colonic Diseases

Interventions

LactulosePolyethylene Glycols

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsEthylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Central Study Contacts

Hui Jia, MD

CONTACT

86-0571-56006821JIAHUIFMMU@163.COM

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Gastroenterology

Study Record Dates

First Submitted

January 30, 2021

First Posted

March 11, 2021

Study Start

May 1, 2021

Primary Completion

October 30, 2021

Study Completion

December 31, 2021

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share