Examining the Effect of Ondansetron on Bowel Prep Success

NCT ID: NCT05439772

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-07-01

Brief Summary

This is a pilot randomized-controlled trial assessing the utility of ondansetron for improving pediatric pre-colonoscopy bowel prep outcomes using the boston bowel preparation score, as well as assessing the impact on patient experience of bowel preparation.

Detailed Description

The study will compare two approaches to pre-colonoscopy cleanout, one with traditional laxatives only, and one with laxatives + anti-emetic therapy. The medication to be added will be Ondansetron (brand name: Zofran). Classically, the bowel prep entails drinking large amounts of water with an osmotic laxative and being only on a liquid diet the day prior to the procedure. Drinking this mixture of water with an osmotic laxative may cause nausea and discomfort in some patients that may prevent them from finishing the bowel prep. This will therefore affect the visualization of the colon during the procedure, as there will still be retained, hard stool. Having large amounts of stool in the colon during the procedure can make the colonoscopy more difficult, takes a longer time to complete, can make the study inconclusive, unable to properly diagnose, and difficult to take biopsies. This study assesses the impact of anti-emetic medication (ondansetron) on the bowel prep experience with the goal of improving participant tolerance and preparation success. This will eliminate concern for retained stool and less chance of cancelling a procedure due to improper bowel prep.

Conditions

Abdominal Pain; Inflammatory Bowel Diseases; Eosinophilic Gastroenteritis; Diarrhea; Hematochezia; Weight Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control

Pediatric patients between the ages of 2-20 who have a clinical indication for colonoscopy, who will undergo standard colonoscopy preparation of polyethylene glycol and bisacodyl

Group Type: NO_INTERVENTION

No interventions assigned to this group

Ondansetron

Pediatric patients between the ages of 2-20 who have a clinical indication for colonoscopy, who will undergo standard colonoscopy preparation of polyethylene glycol and bisacodyl with the addition of one dose of ondansetron prior to initiating bowel preparation.

Group Type: EXPERIMENTAL

Ondansetron

Intervention Type: DRUG

Patient will take one dissolvable tablet of ondansetron prior to initiating PEG consumption.

Interventions

Ondansetron

Patient will take one dissolvable tablet of ondansetron prior to initiating PEG consumption.

Intervention Type: DRUG

Other Intervention Names

Zofran

Eligibility Criteria

Inclusion Criteria

• Age >2, <20
• clinically indicated for a colonoscopy

Exclusion Criteria

• known arrhythmia or long QT

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York - Downstate Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Wallach, MD

Role: PRINCIPAL_INVESTIGATOR

SUNY Downstate HSU

Locations

SUNY Downstate University Hospital of Brooklyn

Brooklyn, New York, United States

Countries

United States

References

Arostegui D, Armaly P, Castro Ochoa K, Lemus VV, Peshimam J, Sharma S, Schwarz S, Wallach T. Pilot Study of Ondansetron in Improvement of Pediatric Colonoscopy Preparation Outcomes at an Urban Academic Center. JPGN Rep. 2023 Sep 8;4(4):e366. doi: 10.1097/PG9.0000000000000366. eCollection 2023 Nov.

Reference Type: DERIVED

PMID: 38034452 (View on PubMed)

Other Identifiers

1650686-6

Identifier Type: -

Identifier Source: org_study_id