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OpenTrials
Completed

NCT Number: NCT07605897

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

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.

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Key information

Conditions

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

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Central Virginia VA Health Care System

Richmond, Virginia, 23249, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Patient acceptance/satisfaction

    Time frame: Periprocedural

    Measure: Scores on a designed survey evaluating acceptance, ease of following instructions and willingness to repeat the preparation.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

Other outcomes

  1. Irrigation and suction time

    Time frame: Periprocedural

    Time spent on irrigation and suction during colonoscopy, measured in minutes

  2. Colonoscopy withdrawal time

    Time frame: Periprocedural

    Time from cecum to scope removal, measured in minutes

  3. Total colonoscopy procedure time

    Time frame: Periprocedural

    Total time from scope insertion to removal, measured in minutes

  4. Cecal intubation rate

    Time frame: Periprocedural

    Proportion of subjects with successful cecal intubation

  5. Adenoma detection rate

    Time frame: Periprocedural

    Proportion of subjects with at least one adenoma detected

  6. Adenomas per colonoscopy

    Time frame: Periprocedural

    Mean number of adenomas detected per colonoscopy

  7. Presence of diverticulosis

    Time frame: Periprocedural

    Proportion of subjects with diverticulosis identified during colonoscopy

  8. Time to first bowel movement

    Time frame: Periprocedural

    Interval from ingestion of bowel preparation laxative to the first bowel movement

Sponsors and collaborators

Lead sponsor

Joseph Spataro

Fed

Collaborators

  • Happy Colon Foods

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 26, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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