Bowel Prep Options for Colorectal Cancer Screening

(COOP SIT Trial)

Overseen By Tasha Rhymes, M.S. Ed.

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Morehouse School of Medicine

Disqualifiers: Under 18, Pregnant, Nursing, Incarcerated, 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: 3

Duration: 1-2 days

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two bowel prep methods for individuals scheduled for a colonoscopy: low-volume tablets (Suflave/Sutab) and a traditional liquid solution (Golytely). Researchers seek to determine patient preference, assess tolerance, and evaluate the effectiveness of each method in preparing the colon. Participants will complete surveys before and after their colonoscopy to share their experiences. Adults with an upcoming colonoscopy who understand English or Spanish may be suitable for this trial. Both prep methods have FDA approval, ensuring no added health risks. As a Phase 4 trial, this research explores how these FDA-approved methods benefit more patients, offering an opportunity to contribute to improving colonoscopy preparation.

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 both Sutab and Suflave are safe for adults to use before a colonoscopy to clean out the bowel. Sutab, available in tablet form, may cause stomach issues like nausea in about 52% of users. These issues are common but usually not serious for most people.

Suflave, a liquid option, is also effective, with about 35% of users experiencing mild discomfort. These reactions are generally easy to manage.

Both Sutab and Suflave have FDA approval for colon cleaning, indicating their safety for this purpose. Prospective trial participants should know that these treatments are widely used and tolerated by many. Always consult a healthcare provider about any concerns to find the best option. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these bowel prep options because they offer varied and potentially more palatable ways to prepare for a colonoscopy. Golytely, a common choice, requires drinking a large volume of liquid, which can be challenging for many. Sutab, on the other hand, is a tablet-based option that might be easier to consume, especially for those who struggle with liquid preps. Sulfave stands out with its lemon-lime taste and low volume, potentially making it more tolerable. These new options aim to improve patient comfort and compliance, which are crucial for effective colorectal cancer screening.

What evidence suggests that this trial's bowel preparation methods could be effective for colorectal cancer screening?

This trial will compare different bowel preparation options for colorectal cancer screening. Studies have shown that Sutab, one of the treatments participants may receive, effectively cleans the bowel before a colonoscopy, with about 92% of participants achieving a clean colon. Research indicates that Sutab works as well as other common methods and remains effective even for individuals with constipation. Another treatment option in this trial, Sulfave, requires drinking less liquid and also performs well, with an 89% success rate. This preparation aids doctors in identifying issues like polyps, which are growths in the colon that can become cancerous. Both Sutab and Sulfave are safe and effective at cleaning the colon, facilitating the detection of any problems by doctors. ^{5 6 7 8 9}

Who Is on the Research Team?

Jesus M Luevano, MD, MS

Principal Investigator

Morehouse School of Medicine

Are You a Good Fit for This Trial?

The COOP SIT trial is for adults over 18 with upcoming colonoscopy appointments who can consent in English or Spanish. It's not suitable for those unable to follow the prep instructions or allergic to the ingredients.

Inclusion Criteria

I am over 18, can consent in English or Spanish, and am scheduled for an outpatient colonoscopy. I may have had colorectal cancer or surgery before.

Exclusion Criteria

Pregnant or nursing women

Patient is incarcerated.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to one of the two bowel preparation methods (Suflave/Sutab or Golytely) prior to their scheduled colonoscopy appointments.

1-2 days

1 visit (in-person) for colonoscopy

Follow-up

Surveys are conducted both before and after the procedures to evaluate patient experience, satisfaction, and tolerance.

1-2 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Golytely
• Sulfave
• Sutab

Trial Overview This study compares two bowel prep methods before a colonoscopy: low-volume tablets (Suflave/Sutab) and standard liquid Golytely. Participants will be randomly assigned to one method and surveyed on their experience.

How Is the Trial Designed?

Group I: Sutab Experimental Treatment 1 Intervention

SUTAB comes in a kit that contains two medication bottles and a cup for water. Each bottle contains 12 tablets (pills). You'll take 12 pills (one bottle) with water from the cup the night before your exam. Later that evening, drink two more cups of water. Fill the cup to the line each time. Then, six hours before your exam, repeat all three of those steps.

Group II: Sulfave Experimental Treatment 1 Intervention

Suflave is a combination, osmotic prescription laxative that may be used to cleanse the bowel in preparation for colonoscopy in adults. Suflave contains polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride, and is supplied as a powder that is mixed with a low volume of water before consuming. It tastes like a lemon-lime sports drink. Drink 8 ounces of the solution every 15 minutes until the bottle is empty, and then drink an additional 16 ounces of water during the evening. One dose of Suflave is equal to one bottle plus one flavor-enhancing packet.

Group III: Golytely Active Control 1 Intervention

GoLYTELY is a prescription medicine used by adults to clean the colon before a colonoscopy or barium enema X-ray examination. GoLYTELY cleans your colon by causing you to have diarrhea (loose stools). Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. Drink reconstituted solution at a rate of 8 ounces every 10 minutes, until 4 liters are consumed, or rectal effluent is clear.

Who Is Running the Clinical Trial?

Morehouse School of Medicine

Lead Sponsor

Trials

22

Recruited

16,300+

Citations

1. suflave.com suflave.com/hcp/Efficacy-6

Efficacy ADR was 35% in patients taking SUFLAVE Benchmark for ADRs: 25% overall, 30% in men, 20% in women Achieving an ADR >33.5% minimizes the probability of missing ...

2. cancertherapyadvisor.com cancertherapyadvisor.com/news/suflave-a-low-volume-colonoscopy-preparation-gets-fda-approval/

Suflave, a Low-Volume Colonoscopy Preparation, Gets ... The same success was achieved in 89% (n=212/239) of patients who received the active comparator in study 1 (polyethylene glycol 3350, sodium ...

3. bmcgastroenterol.biomedcentral.com bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-025-03885-0

A randomized, controlled trial of oral sulfate solution versus ... The magnesium sulfate, sodium sulfate, and potassium sulfate concentrated oral solution is a novel, safe, and effective bowel preparation for colonoscopy.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12003215/

Efficacy and safety of oral sulfate solution versus polyethylene ... OSS demonstrated superior adenoma and polyp detection rates. When compared to PEG, patients utilizing OSS achieved higher BBPS scores.

5. gastrojournal.org gastrojournal.org/article/S0016-5085(25)00361-0/fulltext

Optimizing Bowel Preparation Quality for Colonoscopy This document is an update to the 2014 recommendations for optimizing the adequacy of bowel cleansing for colonoscopy from the US ...

6. suflave.com suflave.com/

SUFLAVE™ (polyethylene glycol 3350, sodium sulfate ... Administration of two doses of SUFLAVE are required for a complete preparation for colonoscopy. Each bottle must be reconstituted with water before ingestion.

7. suflave.com suflave.com/HowtoPrep

How to Prep for Your Colonoscopy SUFLAVE is a split-dose (2-day) regimen. A total of 2 bottles are required for complete preparation for colonoscopy. You will take 2 bottles of liquid in two ...

8. asge.org asge.org/docs/default-source/foundation/corporate-partners/550-461-v2_suflave-cva_final.pdf?sfvrsn=b2890a5f_1

FLAVOR CHOICE IN BOWEL PREPARATION Administration of two doses of SUFLAVE are required for a complete preparation for colonoscopy. Each bottle must be reconstituted with water before ingestion.

9. suflave.com suflave.com/hcp/Resources

Resources Administration of two doses of SUFLAVE ™ are required for a complete preparation for colonoscopy. Each bottle must be reconstituted with water before ingestion.