Bowel Preparation for Crohn's and Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Manitoba

Disqualifiers: Colorectal resection, Renal insufficiency, Heart failure, Cirrhosis, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Bi-PegLyte, KleanLyte for bowel preparation in patients with Crohn's and Ulcerative Colitis?

Research shows that low-volume polyethylene glycol (PEG) solutions, like those in Bi-PegLyte and KleanLyte, are effective and well-tolerated for bowel preparation in patients with inflammatory bowel diseases, such as Crohn's and Ulcerative Colitis. ^{1 2 3 4 5}

How is the bowel preparation treatment Bi-PegLyte, KleanLyte unique for Crohn's and Ulcerative Colitis?

Bi-PegLyte, KleanLyte is unique because it offers a low-volume bowel preparation option, which can be more tolerable for patients with Crohn's and Ulcerative Colitis who often struggle with the large volumes required by standard preparations. This can improve compliance and comfort during colonoscopy preparation. ^{1 2 4 5 6}

Research Team

Eligibility Criteria

This trial is for adults over 18 with Crohn's disease or ulcerative colitis who are scheduled for an outpatient colonoscopy. It aims to find the best bowel prep laxative.

Inclusion Criteria

I have Crohn's disease or ulcerative colitis and am scheduled for a colonoscopy.

I am older than 18 years.

I am not currently hospitalized.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either oral sulfate solution (OSS) or 2L polyethylene glycol (PEG) solution for bowel preparation before colonoscopy

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after colonoscopy, including assessment of Crohn's disease or ulcerative colitis flares

1 month

1 phone call

Long-term follow-up

Participants are monitored for long-term outcomes such as bowel cleanliness and patient experience

1 year

Treatment Details

Interventions

• Bi-PegLyte (Laxative)
• KleanLyte (Laxative)

Trial Overview The study compares two laxatives, Bi-PegLyte and KleanLyte, to see which one works better and is easier to tolerate when preparing for a colonoscopy in individuals with IBD.

Participant Groups

Group I: 2L PEG Active Control 1 Intervention

Group II: OSS Active Control 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Manitoba Winnipeg, Canada

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Patients Recruited

209,000+

Canadian IBD Research Consortium (CIRC)

Collaborator

Trials

1

Patients Recruited

420+

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of very low-volume bowel preparation in patients with inflammatory bowel diseases. [2023] An adequate bowel preparation is essential for a quality colonoscopy. Patients with inflammatory bowel disease (IBD) show low compliance with bowel preparation due to the large volume of lavage solution to be ingested, especially if active symptoms are present, and the frequency of having a colonoscopy. We evaluated the efficacy and tolerability of a very low-volume (VLV) polyethylene glycol (PEG)-based solution in patients with IBD.

2. Germany pubmed.ncbi.nlm.nih.gov

Colon cleansing efficacy and safety with 1 L NER1006 versus 2 L polyethylene glycol + ascorbate: a randomized phase 3 trial. [2019] Polyethylene glycol (PEG)-based bowel preparations are effective cleansers but many require high-volume intake. This phase 3, randomized, blinded, multicenter, parallel-group, central reader-assessed study assessed the 1 L PEG NER1006 bowel preparation vs. standard 2 L PEG with ascorbate (2LPEG).

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of TJP-008 Compared to 2 L PEG with Ascorbate in Colon Cleansing: A Randomized Phase 3 Trial. [2022] Polyethylene glycol (PEG)-based bowel preparations are effective cleansing agents for colonoscopy. However, they require relatively large volumes to be used even with agents such as 2 L PEG with ascorbate (2LPEG). This phase 3, randomized, single-blinded, multicenter, parallel-group study compared the efficacy of 1 L PEG with high-dose ascorbate, TJP-008, to 2LPEG.

4. Germany pubmed.ncbi.nlm.nih.gov

A randomized, blinded, prospective trial to compare the safety and efficacy of three bowel-cleansing solutions for colonoscopy (HSG-01*). [2022] There are conflicting data regarding the optimal bowel preparation for colonoscopy. This study was carried out to compare the efficacy, safety, and tolerability of three widely used bowel lavage solutions: the standard polyethylene glycol-electrolyte solution based on the GoLytely formulation (PEG-EL1; Klean-Prep); a sulphate-free PEG-EL solution based on the NuLytely formulation (PEG-EL2, Endofalk); and a sodium phosphate preparation (NaP, Fleet Phospho-Soda).

5. England pubmed.ncbi.nlm.nih.gov

Efficacy, Tolerability, and Safety of Low-Volume Bowel Preparations for Patients with Inflammatory Bowel Diseases: The French Multicentre CLEAN Study. [2020] Standard high-volume polyethylene glycol [PEG] bowel preparations [PEG-4L] are recommended for patients with inflammatory bowel disease [IBD] undergoing colonoscopy. However, low-volume preparations [≤2 L of active volume] are often used in clinical practice. The aim of this study was to evaluate the efficacy, tolerability, and safety of the various bowel preparations for patients with IBD, including low-volume preparations.

6. Greece pubmed.ncbi.nlm.nih.gov

A comparative study of two methods of colonic cleansing before colonoscopy. [2018] good colonic preparation is essential to perform a complete and safe colonoscopy. The preparation used in the Endoscopy Unit was adopted after testing it against the classic 4-liter polyethylene glicol (PEG) preparation (Klean-Prep). Recently a new 3-liter PEG preparation was commercialised in Portugal, Endo-Falk, which appeared to be simpler and effective. The present study compared the preparation we usually use (a combination of 4 tablets of bisacodyl with 2-liter PEG and enemas) with this new preparation.