MedTrace Logo

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

NCT07605897 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2026-05-26

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

Use of a standardized meal content (food-kit) the day prior to colonoscopy

Low-residue diet food items and scheduled doses of PEG-3350, senna, and magnesium citrate prior to the colonoscopy

DRUG

Polyethylene glycol 3350 - electrolyte solution (GoLYTELY)

Split-dose 4 L PEG-3350 electrolyte lavage solution taken the day before and morning of colonoscopy, combined with 24-hour clear liquid diet.

Sponsors & Collaborators

  • Happy Colon Foods

    collaborator UNKNOWN

  • Joseph Spataro

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2025-06-24
Completion
2025-06-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07605897 on ClinicalTrials.gov