Bowel Preparation for Colonoscopy Among Individuals With... | NCT06298461

Studies
Bowel Preparation for Colonoscopy Among Individuals With Crohn's and Ulcerative Colitis Disease.

NCT06298461

Sponsor

University of Manitoba

Status

Recruiting

Last Update Posted

Jan 8, 2025Actual

Enrollment

418Estimated

Phase

Phase 4

Conditions

Crohn Disease
Ulcerative Colitis

Interventions

KleanLyte
Bi-PegLyte

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 4, 2024Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

May 2026Estimated

First Submitted Date

Feb 6, 2024

First Submission Date that Met QC Criteria

Feb 29, 2024

First Posted Date

Mar 7, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2025

Last Update Posted Date

Jan 8, 2025Actual

Name	Class
Canadian IBD Research Consortium (CIRC)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to compare how effective and how tolerable two different bowel preparation laxatives are for colonoscopy. The aim is to compare oral sulfate solution (OSS) to another laxative called 2L polyethylene glycol (PEG) solution to see which is more effective and more tolerable by individuals with IBD (Crohn's disease or Ulcerative colitis).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

418Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OSS	Active Comparator		Drug: KleanLyte
2L PEG	Active Comparator		Drug: Bi-PegLyte

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KleanLyte	Drug	Laxative for colonoscopy bowel preparation	OSS
Bi-PegLyte

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of bowel cleanliness	The primary outcome will be adequate quality of bowel cleanliness. Proportion with adequate cleansing will be measured by Boston Bowel Preparation Scale Score ≥2 in all segments.	1 year
Quality of bowel cleanliness	The primary outcome will be adequate quality of bowel cleanliness. Proportion with adequate cleansing will be measured by the Ottawa scale score as a binary adequate/inadequate score (≤7) will be recorded.	1 year

Secondary Outcomes

Measure	Description	Time Frame
Volume of laxative intake	Will compare completion of laxative intake.	1 year
Endoscopic Outcomes	Will compare dysplasia detection rate.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Crohn's disease or ulcerative colitis patients scheduled or about to be scheduled for colonoscopy.
Age > 18 years
Out-patients

Exclusion Criteria:

Prior subtotal or total colorectal resection
Contraindications to use of 2L polyethylene glycol (2L-PEG) or Oral Sulfate Solution (OSS): Known renal insufficiency, congestive heart failure, cirrhosis, severe electrolyte imbalance.
Colonoscopy being repeated because of poor preparation in the preceding six months.
Allergies to the employed bowel preparations
Toxic megacolon, ileus, suspected or diagnosed bowel obstruction.
IBD patients thought to be too sick to undergo a full colonoscopy preparation in the opinion of the investigator/treating physician; hospitalized crohn's disease or ulcerative colitis patients.
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jane Castelli	Contact	289-880-3609		jcast@mcmaster.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Manitoba	Recruiting	Winnipeg	Manitoba	H2X 1R9	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

No individual participant data will be shared.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease
D003093	Colitis, Ulcerative

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

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Browse Branches

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