NCT07605897CompletedPhase 4
A Single-Center, Randomized, Prospective, Single-Blinded Study to Assess the Safety, Quality, and Tolerance of a Bowel Preparation Using a Food Kit With Laxatives in a United States Veteran Population
Joseph Spataro1 site in 1 country57 target enrollmentStarted: November 1, 2022Last updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 57
- Locations
- 1
Study Overview
Brief Summary
The main purpose of this research study is to learn if an alternative bowel preparation (bowel prep) for colonoscopy is safe, tolerable and effective as compared to the standard bowel prep.
Participants are randomly assigned to receive one of the following bowel cleansing regimens for colonoscopy.
- Standard Bowel Prep which includes a clear liquid diet the day before the scheduled procedure and two doses of a laxative, polyethylene glycol 3350 (PEG-3350) taken with 4 liters of water.
- Happy Colon Foods Bowel Prep which begins the day before the scheduled procedure and contains various low residue foods (foods that are easily digested and absorbed), and seven doses of laxatives including PEG-3350 taken with a total of about 4 liters of water, senna tablets, and one dose of magnesium citrate.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Investigator)
Masking Description
single-blinded endoscopist
Eligibility Criteria
- Ages
- 18 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •- Veterans undergoing index colonoscopy for colorectal cancer screening, including follow-up colonoscopy after a positive non-invasive stool-based test (e.g., fecal immunochemical test)
Exclusion Criteria
- •Personal history of colorectal cancer
- •Inflammatory bowel disease
- •Prior colon resection
- •Antithrombotic therapy precluding polypectomy
- •Pregnancy
- •Hospitalization at the time of the scheduled procedure
- •Celiac disease (food kit contained gluten products)
- •Prior colonoscopy (cognitive bias)
- •Chronic kidney disease stage 3 or higher
- •Age 70 years or older.
Investigators
Joseph Spataro
Staff Physician
Hunter Holmes Mcguire Veteran Affairs Medical Center
Study Sites (1)
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