Recruiting PHASE4 Crohn Disease

New treatment option for Crohn Disease

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

ClinicalTrials.gov ID: NCT06298461

What this study is testing

What is KleanLyte?

KleanLyte is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for crohn disease.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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).
  • Phase 4: studies an already-approved treatment

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

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

You likely can't join if

  • 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...
  • 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...
See the full eligibility criteria
Who can join
  • Crohn's disease or ulcerative colitis patients scheduled or about to be scheduled for colonoscopy.
  • Age \> 18 years
  • Out-patients
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Winnipeg, Manitoba, Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Winnipeg, Manitoba, Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.