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

NCT07605897 | Completed Phase 4 FDA Drug

• 1 other identifier: IRBNet ID: 1689988
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

colonoscopy; bowel preparation

Outcome Measures

Primary Outcomes (1)

• Patient acceptance/satisfaction

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

  Periprocedural

Secondary Outcomes (3)

• Quality of bowel preparation

  During colonoscopy (single procedure)

• Patient-reported symptoms during bowel preparation

  Periprocedural

• Adverse events during bowel preparation

  Periprocedural

Other Outcomes (8)

• Irrigation and suction time

  Periprocedural

• Colonoscopy withdrawal time

  Periprocedural

• Total colonoscopy procedure time

  Periprocedural

Study Arms (2)

Experimental: Food Kit with Laxatives (Happy Colon Foods)

EXPERIMENTAL

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

Control: Standard GoLYTELY Split-Dose Prep

ACTIVE COMPARATOR

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)

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

Experimental: Food Kit with Laxatives (Happy Colon Foods)

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.

Control: Standard GoLYTELY Split-Dose Prep

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joseph Spataro: lead
• Happy Colon Foods: collaborator

Study Sites (1)

Central Virginia VA Health Care System

Richmond, Virginia, 23249, United States

Location

Related Publications (23)

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MeSH Terms

Interventions

Golytely

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: single-blinded endoscopist
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Physician

Model Details: Feasibility study comparing low-fiber vs clear-liquid diet before colonoscopy

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 26, 2026
• Study Start: November 1, 2022
• Primary Completion: June 24, 2025
• Study Completion: June 24, 2025
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)