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

May 18, 2026 updated by: Joseph Spataro

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Central Virginia VA Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient acceptance/satisfaction
Time Frame: Periprocedural
Measure: Scores on a designed survey evaluating acceptance, ease of following instructions and willingness to repeat the preparation.
Periprocedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of bowel preparation
Time Frame: During colonoscopy (single procedure)
Measure: Boston Bowel Preparation Scale (BBPS) score in right, transverse, and left colon; total score 0-9. Adequate bowel preparation defined as total BBPS ≥ 6 with each segment score ≥ 2; proportion of patients achieving adequate prep compared between groups.
During colonoscopy (single procedure)
Patient-reported symptoms during bowel preparation
Time Frame: Periprocedural
Patient-reported symptoms (abdominal pain, cramping, bloating, nausea, vomiting, headaches, weakness, hunger, sleep difficulties) scored on a 5-point Likert scale (1 = none to 5 = severely distressing).
Periprocedural
Adverse events during bowel preparation
Time Frame: Periprocedural
Proportion of subjects with adverse events, defined as any symptom scored as 5 (severely distressing) on the Likert scale.
Periprocedural

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Irrigation and suction time
Time Frame: Periprocedural
Time spent on irrigation and suction during colonoscopy, measured in minutes
Periprocedural
Colonoscopy withdrawal time
Time Frame: Periprocedural
Time from cecum to scope removal, measured in minutes
Periprocedural
Total colonoscopy procedure time
Time Frame: Periprocedural
Total time from scope insertion to removal, measured in minutes
Periprocedural
Cecal intubation rate
Time Frame: Periprocedural
Proportion of subjects with successful cecal intubation
Periprocedural
Adenoma detection rate
Time Frame: Periprocedural
Proportion of subjects with at least one adenoma detected
Periprocedural
Adenomas per colonoscopy
Time Frame: Periprocedural
Mean number of adenomas detected per colonoscopy
Periprocedural
Presence of diverticulosis
Time Frame: Periprocedural
Proportion of subjects with diverticulosis identified during colonoscopy
Periprocedural
Time to first bowel movement
Time Frame: Periprocedural
Interval from ingestion of bowel preparation laxative to the first bowel movement
Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joseph Spataro

Collaborators

Happy Colon Foods

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

June 24, 2025

Study Completion (Actual)

June 24, 2025

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 18, 2026

First Posted (Actual)

May 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBNet ID: 1689988

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data from this single-center VA study will not be shared outside the institution due to privacy and confidentiality protections for Veterans and lack of an approved external data-sharing mechanism. Aggregate results will be disseminated through presentations and peer-reviewed publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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