SUPREP vs Golytely for Colon Cancer Screening

Overseen By Darrell F Barker MD, FACG, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Eisenhower Army Medical Center

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: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if the Golytely or SUPREP bowel preparation works more effectively in bowel cleansing for colorectal cancer screening with colonoscopy in patients with diabetes. The main questions this study aims to answer are:

1. Is there a significant difference in bowel prep cleanse between Golytely and SUPREP in patients with diabetes based on the Boston Bowel Prep Score (BBPS) as assessed by blinded, skilled endoscopists?

2. Is there a significant difference in patients' tolerance between the bowel preparations as assessed by the validated Mayo Bowel Prep Tolerability Form (MBPTF)?

Participants will:

* Be randomized to take either Golytely or SUPREP bowel preparation prior to their colonoscopy

* Complete the MBPTF on the procedure date prior to the scheduled colonoscopy

* Undergo a standardized screening colonoscopy during which time a blinded endoscopist will document the participant's BBPS

The research team hypothesizes that SUPREP will have a significant difference in tolerability (based on MBPTF), while exhibiting no difference in bowel cleanse (based on BBPS) in the diabetic patient population.

Are You a Good Fit for This Trial?

This trial is for diabetic patients who need a colonoscopy to screen for colon cancer. Participants will be randomly assigned to use either Golytely or SUPREP bowel prep. They must complete a tolerability form and undergo the screening where a doctor, unaware of which prep they used, scores the cleanliness of their bowels.

Inclusion Criteria

Participants having provided informed consent with signature on informed consent form after full discussion of all requirements and possible risks

Diabetic volunteer as defined per current ACP guidelines, any type of DM

I am 18 years old or older.

Exclusion Criteria

I am able to understand and consent to participate in the study.

Prior use of any investigational drug in the preceding 6 months

Pregnant or breast-feeding women or those planning to become pregnant during the study

What Are the Treatments Tested in This Trial?

Interventions

• Golytely
• SUPREP

Trial Overview

The study compares two bowel cleansing methods—Golytely and SUPREP—to see which one works better for diabetics before a colonoscopy. It measures how well each cleans out the bowels using the Boston Bowel Prep Score and checks patient comfort with the Mayo Bowel Prep Tolerability Form.

How Is the Trial Designed?

Group I: Diabetic patients undergoing bowel prep for screening colonoscopy using Golytely Active Control 1 Intervention

Group II: Diabetic patients undergoing bowel prep for screening colonoscopy using SUPREP Active Control 1 Intervention

Who Is Running the Clinical Trial?

Eisenhower Army Medical Center

Lead Sponsor

Trials

9

Recruited

720+