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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores which of two laxatives, Bi-PegLyte and KleanLyte, works better for individuals with Crohn's disease or ulcerative colitis who require a colonoscopy. The study compares an oral sulfate solution with a polyethylene glycol solution to determine which cleans the bowel more effectively and is easier for patients to tolerate. Individuals with Crohn's or ulcerative colitis scheduled for a colonoscopy may be suitable candidates for this trial. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, and this research aims to understand how it benefits more patients.

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 is the safety track record for these treatments?

Research has shown that the bowel prep solution Bi-PegLyte should be used with caution in people with severe ulcerative colitis. Some patients have experienced minor issues like fever and vomiting. Another option, KleanLyte, might cause serious bowel problems, including ulcers. Both solutions are low-volume, making them easier to handle for people with Crohn's or ulcerative colitis. Patients should always consult their doctor to determine the best option. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the bowel preparation treatments, Bi-PegLyte and KleanLyte, because they offer new options for patients with Crohn's and Ulcerative Colitis. Unlike traditional methods, these treatments are designed to be more effective and potentially more comfortable for patients. Bi-PegLyte and KleanLyte are formulated to ensure thorough bowel cleansing, which is crucial for accurate diagnostic procedures and effective management of these conditions. By improving the preparation process, these treatments aim to enhance patient experience and outcomes, setting them apart from existing options.

What evidence suggests that this trial's treatments could be effective for IBD?

This trial will compare two bowel preparation treatments for patients with Crohn's and Ulcerative Colitis. Research has shown that a low-volume PEG-based bowel preparation, such as KleanLyte, was effective in 85.4% of patients with inflammatory bowel disease (IBD). Studies have found that PEG solutions, like Bi-PegLyte, have a high success rate of 96% for proper bowel preparation. Both treatments effectively clean the bowel, which is crucial for a clear colonoscopy. These findings suggest that KleanLyte and Bi-PegLyte are effective options for people with IBD who need bowel prep for a colonoscopy. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10080552/

Quality of bowel preparation in patients with inflammatory ... A high efficacy rate of 96% was shown in the group taking only 4 L PEG-ELS (considering at least acceptable preparation). In contrast, ...

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/466897

Bowel Preparation for Colonoscopy Among Individuals ... The purpose of this study is to compare how effective and how tolerable two different bowel preparation laxatives are for colonoscopy.

3. withpower.com withpower.com/trial/bowel-preparation-for-crohns-and-ulcerative-colitis-d7c90

Bowel Preparation for Crohn's and Ulcerative Colitis 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6020982/

protocol for a systematic review and network meta-analysis Compared with a kit containing 5 mg bisacodyl, there was a greater risk of ischaemic colitis and abdominal cramping. In Canada, there are ...

5. wjgnet.com wjgnet.com/1948-5190/full/v15/i3/133.htm

Quality of bowel preparation in patients with inflammatory ... A high efficacy rate of 96% was shown in the group taking only 4 L PEG-ELS (considering at least acceptable preparation). In contrast, ...

6. pdf.hres.ca pdf.hres.ca/dpd_pm/00058731.PDF

BI-PEGLYTE® - Bowel Prep Kit Bi-PEGLYTE® should be used with caution in patients with severe ulcerative colitis. Patients with impaired gag reflex and patients prone to ...

7. pendopharm.com pendopharm.com/wp-content/uploads/2022/05/BI-PEGLYTE-PI-EN.pdf?x87476

Bi-PEGLYTE Bi-PEGLYTE® should be used with caution in patients with severe ulcerative colitis. Patients with impaired gag reflex and patients prone to ...

8. ctv.veeva.com ctv.veeva.com/study/bowel-preparation-for-colonoscopy-among-individuals-with-crohns-and-ulcerative-colitis-disease

Bowel Preparation for Colonoscopy Among Individuals With ... The purpose of this study is to compare how effective and how tolerable two different bowel preparation laxatives are for colonoscopy.