Cleansing Options in Out-Patient Setting to Improve Tolerance (COOP SIT) Trial

NCT07215000 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2282829
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to compare patient preferences for two bowel preparation options: low-volume tablets (Suflave/Sutab) versus the standard colon preparation using Golytely (polyethylene glycol). The study aims to enroll approximately 300 patients, who will be randomly assigned to one of the two preparation methods in a 2:1 ratio prior to their scheduled colonoscopy appointments. Surveys will be conducted both before and after the procedures. This project will be conducted over a 12-month period and seeks to compare patient experience of both preparation methods in an outpatient setting. The study will evaluate the rate of preparation completion, patient satisfaction, tolerance of the solutions, and the endoscopic adequacy of each method. Eligible participants are patients aged 18 or older with upcoming colonoscopy appointments who can provide informed consent in English or Spanish. There is no health risks associated with this study, as both bowel preparation methods are FDA-approved and commonly used in clinical practice.

Conditions

Colorectal Cancer Screening; Bowel Cleansing for Colonoscopy

Keywords

Colorectal cancer screening; Bowel cleansing for colonoscopy

Outcome Measures

Primary Outcomes (2)

• Patient Experience

  Evaluate the patient experience of the two new colon prep options (low volume and tablets) versus conventional bowel prep in an out-patient setting.

  Until the end of the study

• Edoscopic Adequacy

  Assess endoscopic adequacy of the three bowel cleansing solutions

  Until the end of the study

Secondary Outcomes (1)

• Rate of Completion

  Until the end of the study

Other Outcomes (1)

• Rate of cancellation and patient satisfaction and tolerance

  Until the end of the study

Study Arms (3)

Golytely

ACTIVE COMPARATOR

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.

Drug: Golytely

Sulfave

OTHER

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.

Drug: Sulfave

Sutab

OTHER

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.

Drug: Sutab

Interventions

Golytely DRUG

large volume liquid prep.

Golytely

Sulfave DRUG

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 separate doses. One dose of SUFLAVE is equal to one bottle plus one flavor enhancing packet.

Also known as: polyethylene glycol 3350, sodium sulfaten, potassium chloride, magnesium sulfate

Sulfave

Sutab DRUG

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.

Sutab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over age of 18 years undergoing outpatient colonoscopy for various indications, ability to consent in English or Spanish. Patients will still be allowed to join if there is a history of colorectal cancer or previous surgery

You may not qualify if:

• Patient is less than 18 years of age, any pregnant or nursing women, unable to consent, or patient is incarcerated.

Sponsors & Collaborators

• Morehouse School of Medicine: lead

Study Sites (1)

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

RECRUITING

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MeSH Terms

Interventions

Golytely; polyethylene glycol 3350; Potassium Chloride; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Potassium Compounds; Magnesium Compounds; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Jesus M Luevano, MD, MS

  Morehouse School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia J Liu, MD, MSc

CONTACT

(404) 756-1369; jjliu@msm.edu

Tasha Rhymes, M.S. Ed.

CONTACT

(404) 756-1369; trhymes@msm.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: October 9, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 9, 2025

Record last verified: 2025-10

Locations

US (1)