Bowel Preparation for Crohn's and Ulcerative Colitis

Overseen By Jane Castelli

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Manitoba

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1-2 weeks

418 Participants Needed

Trial Summary

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}

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).

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.

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
• KleanLyte

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: OSS Active Control 1 Intervention

Group II: 2L PEG Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Canadian IBD Research Consortium (CIRC)

Collaborator

Trials

1

Recruited

420+

Findings from Research

A very low-volume (VLV) polyethylene glycol (PEG)-based bowel preparation was effective for colon cleansing in 85.4% of the 103 patients with inflammatory bowel disease (IBD), making it a viable option for those who struggle with larger volumes.

Patients reported high compliance with the VLV solution, with 99% completing the intake and 86.4% willing to use it again for future colonoscopies, indicating good tolerability and acceptance of this preparation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of very low-volume bowel preparation in patients with inflammatory bowel diseases. Neri, B., Scarozza, P., Giannarelli, D., et al.[2023]

In a study of 849 patients undergoing colonoscopy, the 1L PEG NER1006 bowel preparation showed superior overall cleansing success and high-quality cleansing in the right colon compared to the standard 2L PEG with ascorbate, particularly with the evening/morning regimen (N2D).

Both NER1006 regimens (N2D and morning-only N1D) demonstrated comparable safety and tolerability to the standard preparation, making NER1006 an effective low-volume alternative for bowel cleansing.

NCBI (Pubmed)

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. Bisschops, R., Manning, J., Clayton, LB., et al.[2019]

TJP-008, a new low-volume bowel preparation, demonstrated noninferior cleansing efficacy compared to the standard 2L PEG with ascorbate (2LPEG) in a study of 293 patients undergoing colonoscopy.

TJP-008-2 showed a significantly higher bowel cleansing score in the right colon compared to 2LPEG, indicating it may provide better quality cleansing while being easier to consume due to its lower volume.

NCBI (Pubmed)

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. Koo, JS., Byeon, JS., Lee, BI., et al.[2022]

In a study of 185 patients undergoing elective colonoscopy, the standard polyethylene glycol-electrolyte solution (PEG-EL1) was found to be significantly more effective for bowel cleansing compared to both a sulphate-free PEG-EL solution (PEG-EL2) and a sodium phosphate preparation (NaP).

PEG-EL1 achieved better colonoscopic visualization and higher satisfaction ratings, with over 90% of patients rated as having 'very good' or 'good' cleansing, while the NaP group experienced more adverse events like nausea and abdominal pain.

NCBI (Pubmed)

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*). Ell, C., Fischbach, W., Keller, R., et al.[2022]

In a study of 278 patients with inflammatory bowel disease (IBD), low-volume bowel preparations (PEG-2L and sodium picosulfate) showed significantly better efficacy and tolerability compared to the standard high-volume PEG-4L preparation, with only 51.2% of PEG-4L patients achieving the desired efficacy outcome.

The sodium picosulfate preparation had the highest efficacy and tolerability profile, with 93.8% of patients completing the intake, compared to only 59.5% for PEG-4L, indicating that low-volume options may be preferable for patients undergoing colonoscopy.

NCBI (Pubmed)

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. Briot, C., Faure, P., Parmentier, AL., et al.[2020]

In a study of 305 patients undergoing colonoscopy, the traditional preparation method (4 tablets of bisacodyl with 2-liter PEG and enemas) resulted in better colonic cleanliness, with 57.5% rated as good preparation compared to only 33.1% for the new 3-liter PEG preparation, Endo-Falk.

Despite the new preparation being simpler, it was less effective in achieving optimal colonic preparation, which is crucial for a complete and safe colonoscopy, as indicated by the significant difference in preparation quality (p < 0.001).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study of two methods of colonic cleansing before colonoscopy. Cremers, MI., Mangualde, J., Vieira, AM., et al.[2018]

References

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

Efficacy and tolerability of very low-volume bowel preparation in patients with inflammatory bowel diseases. [2023]

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]

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]

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]

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]

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

A comparative study of two methods of colonic cleansing before colonoscopy. [2018]