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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

418 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-04

Study Completion Date

2026-05-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Crohn Disease Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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OSS

Group Type ACTIVE_COMPARATOR

KleanLyte

Intervention Type DRUG

Laxative for colonoscopy bowel preparation

2L PEG

Group Type ACTIVE_COMPARATOR

Bi-PegLyte

Intervention Type DRUG

Laxative for colonoscopy bowel preparation

Interventions

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KleanLyte

Laxative for colonoscopy bowel preparation

Intervention Type DRUG

Bi-PegLyte

Laxative for colonoscopy bowel preparation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Prior subtotal or total colorectal resection
2. Contraindications to use of 2L polyethylene glycol (2L-PEG) or Oral Sulfate Solution (OSS): Known renal insufficiency, congestive heart failure, cirrhosis, severe electrolyte imbalance.
3. Colonoscopy being repeated because of poor preparation in the preceding six months.
4. Allergies to the employed bowel preparations
5. Toxic megacolon, ileus, suspected or diagnosed bowel obstruction.
6. 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.
7. Pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No