Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05439772
Other study ID # 1650686-6
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 1, 2021
Est. completion date July 1, 2023

Study information

Verified date December 2023
Source State University of New York - Downstate Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date July 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group 2 Years to 20 Years
Eligibility Inclusion Criteria: - Age >2, <20 - clinically indicated for a colonoscopy Exclusion Criteria: - known arrhythmia or long QT

Study Design


Intervention

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

Locations

Country Name City State
United States SUNY Downstate University Hospital of Brooklyn Brooklyn New York

Sponsors (1)

Lead Sponsor Collaborator
State University of New York - Downstate Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Boston Bowel Preparation Scale validated scoring system of bowel preparation 24 hours after dose
Secondary Symptoms associated with Bowel Prep assess participant reports of pain, bloating, nausea, and vomiting associated with bowel preparation 24 hours after dose
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04046913 - The ADDapt Diet in Reducing Crohn's Disease Inflammation N/A
Active, not recruiting NCT04989907 - A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland
Recruiting NCT05316584 - A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy N/A
Active, not recruiting NCT04990258 - A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima®SC
Completed NCT06216223 - Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients N/A
Enrolling by invitation NCT06015789 - Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care
Recruiting NCT06065995 - StoMakker Mobile Application N/A
Recruiting NCT03282786 - Comparison of Carbon Dioxide (CO2) to Air Insufflation in Colonoscopy in Patients With Inflammatory Bowel Disease N/A
Recruiting NCT06002074 - SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases N/A
Recruiting NCT04960826 - Study of an Environmental Risk Factor in Crohn's Disease
Recruiting NCT05413941 - Internet-based Cognitive Behavioral Therapy in Inflammatory Bowel Disease N/A
Completed NCT03668249 - A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
Completed NCT00721812 - A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686 Phase 1
Recruiting NCT05809999 - IBD Neoplasia Surveillance RCT N/A
Recruiting NCT04138225 - The Ecological Role of Yeasts in the Human Gut
Recruiting NCT04991324 - Cholecalciferol Comedication in IBD - the 5C-study Phase 3
Completed NCT03173144 - Chronic Inflammatory Disease, Lifestyle and Treatment Response
Not yet recruiting NCT05043818 - A Clinical Study on the Screening of Intestinal Biomarkers in IBD Patients With Depression
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Not yet recruiting NCT02858557 - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases N/A