Examining the Effect of Ondansetron on Bowel Prep Success

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Pain; Diarrhea; Inflammatory Bowel Diseases; Weight Loss; Eosinophilic Gastroenteritis; Hematochezia
• Intervention / Treatment: Drug: Ondansetron

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Thomas Wallach, MD; Phone Number: 718-270-1313; Email: thomas.wallach@downstate.edu
• Study Contact Backup: Name: Dalia Arostegui, MD; Email: dalia.arostegui@downstate.edu

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate University Hospital of Brooklyn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• known arrhythmia or long QT

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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
Experimental: 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.	Drug: Ondansetron; Patient will take one dissolvable tablet of ondansetron prior to initiating PEG consumption.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston Bowel Preparation Scale	validated scoring system of bowel preparation	24 hours after dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms associated with Bowel Prep	assess participant reports of pain, bloating, nausea, and vomiting associated with bowel preparation	24 hours after dose

Collaborators and Investigators

• Sponsor: State University of New York - Downstate Medical Center
• Investigators: Principal Investigator: Thomas Wallach, MD, SUNY Downstate HSU

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: colonoscopy; bowel preparation; ondansetron
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Immune System Diseases; Hypersensitivity, Immediate; Pain; Neurologic Manifestations; Hematologic Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Hemorrhage; Body Weight; Intestinal Diseases; Hypersensitivity; Esophageal Diseases; Esophagitis; Body Weight Changes; Leukocyte Disorders; Eosinophilia; Inflammatory Bowel Diseases; Diarrhea; Weight Loss; Abdominal Pain; Gastroenteritis; Eosinophilic Esophagitis; Gastrointestinal Hemorrhage; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Antipruritics; Ondansetron
• Other Study ID Numbers: 1650686-6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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