Assessment of Safety, Quality, and Acceptance of a Bowel Preparation Using a Food Kit With Laxatives

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Joseph Spataro
Study ID
NCT07605897
Phase
PHASE4
Status
Completed

Conditions

  • Bowel Preparation for Colonoscopy
  • Bowel Preparation, Efficacy, Tolerability, Safety
  • Colon Cancer Screening

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • Use of a standardized meal content (food-kit) the day prior to colonoscopy — OTHER
    Low-residue diet food items and scheduled doses of PEG-3350, senna, and magnesium citrate prior to the colonoscopy
  • Polyethylene glycol 3350 - electrolyte solution (GoLYTELY) — DRUG
    Split-dose 4 L PEG-3350 electrolyte lavage solution taken the day before and morning of colonoscopy, combined with 24-hour clear liquid diet.

Study Details

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.

Key Dates

Start date
Nov 1, 2022
Status verified
May 2026
Primary completion
Jun 24, 2025
Completion
Jun 24, 2025

Study Design

Enrollment
57 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Experimental: Food Kit with Laxatives (Happy Colon Foods)
    Patients receive a commercially available prepackaged food and laxative kit (Happy Colon Foods) starting 24 hours before colonoscopy, including a low-residue diet and intermittent laxative regimen with PEG-3350 powder, senna tablets, and a single dose of magnesium citrate, following written and visual instructions.
  • Active Comparator: Control: Standard GoLYTELY Split-Dose Prep
    Patients receive standard colonoscopy bowel preparation using a clear liquid diet for 24 hours before the procedure and split-dose 4 L polyethylene glycol 3350 electrolyte solution (PEG-3350; GoLYTELY) prior to the scheduled colonoscopy.

Primary Outcome Measure

Patient acceptance/satisfaction [ Time Frame: Periprocedural ]

Locations (1)

FacilityCityStateZIPSite coordinators
Central Virginia VA Health Care SystemRichmondVirginia23249-

Find similar trials in Richmond, VA

By research site
Central Virginia VA Health Care System· Richmond, VA

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