At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Use of a standardized meal content (food-kit) the day prior to colonoscopy and Polyethylene glycol 3350 - electrolyte solution (GoLYTELY) for Bowel Preparation, Efficacy, Tolerability, Safety and 2 related conditions. Completed, enrolled 57 participants across 1 site.
Detailed 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 Details
Timeline
Interventions
Low-residue diet food items and scheduled doses of PEG-3350, senna, and magnesium citrate prior to the colonoscopy
Split-dose 4 L PEG-3350 electrolyte lavage solution taken the day before and morning of colonoscopy, combined with 24-hour clear liquid diet.