- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01164410
The Efficacy Side Effects and the Tolerance of Polyethylene Glycol 3350 as a Bowel Prep in Children
Bowel preparation solutions containing Polyethylene Glycol is a commonly used preparation of the colon for colonoscopy in children. However young children and adolescents often subject to the volume and taste of liquid that must be consumed for an adequate preparation. Currently almost all of our patients experience some difficulty with completing the colyte preparation and approximately 10-20% is unable to achieve adequate cleansing due to inability to drink the solution. The standard colyte solution is salty and often impedes children from drinking the required amount of colyte preparation for adequate colon cleansing. Miralax has been used at a dose of 1.5gm/kg/day to a maximum of 102 gms /day as four day prep Four day bowel prep can be extremely frustrating for the parents and the patients. This may result in low patient acceptance, limiting compliance leading to inadequate colonoscopy. Decreasing the duration of the prep may increase the compliance and provide better colon visualization.
Hence a Cross sectional study looking at the safety,efficacy,tolerability of PEG 3350 mixed in Gatorade G(TM) as a bowel prep in children needs to be conducted. Consent will be obtained from parents and assent will be obtained from patients. Previous laboratory tests for each patient will be reviewed. All patients in the study will be required to consume MiralaxTM/Gatorade GTM the day prior to their procedure. The patients will be given written instructions as to how to much solution to take and how to prepare and consume the solution. The patient shall be maintained on a clear liquid diet the day prior to the procedure. Once patients arrive for the colonoscopy they will be asked to complete a questionnaire regarding their bowel preparation. Prior to the administration of IV fluids, 1ml of blood will be obtained a basic metabolic panel. The patient will then undergo a colonoscopy by routine procedure and technique. The endoscopist will complete a questionnaire when done with the colonoscopy to rate the cleanliness of the colon.
We propose that MiralaxTM combined with Gatorade GTM given the day prior to colonoscopy is a safe, tolerable and efficacious cleansing regimen for colonoscopy in children.
Study Overview
Status
Conditions
Detailed Description
Inclusion Criteria:
- Patients five years old or older that present to the pediatric GI clinic and are capable of taking oral liquids and have been scheduled for a colonoscopy.
- Patients who are able to communicate their discomfort and preferences.
Exclusion Criteria:
- Patients that are neurologically compromised
- Patients in need of emergent colonoscopy
- Patients with known metabolic, endocrine, renal or cardiac conditions.
- Presence of pre-existing ostomy, short bowel syndrome, gastric retention, intestinal obstruction or swallowing difficulties.
- Patients with known electrolyte abnormalities.
- Patients who are allergic to PEG-3350.
- Patients that are known to be pregnant.
- Patients with known fructose intolerance.
- Patient younger than five years old.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44124
- Cleveland Clinic Childrens Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients five years old or older that present to the pediatric GI clinic and are capable of taking oral liquids and have been scheduled for a colonoscopy.
- Patients who are able to communicate their discomfort and preferences.
Exclusion Criteria:
- Patients that are neurologically compromised
- Patients in need of emergent colonoscopy
- Patients with known metabolic, endocrine, renal or cardiac conditions.
- Presence of pre-existing ostomy, short bowel syndrome, gastric retention, intestinal obstruction or swallowing difficulties.
- Patients with known electrolyte abnormalities.
- Patients who are allergic to PEG-3350.
- Patients that are known to be pregnant.
- Patients with known fructose intolerance.
- Patient younger than five years old.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Pediatric Colonoscopy
Patients undergoing colonoscopy in the Department of Pediatric Gastroenterology at the Cleveland Clinic Children's Hospital in Cleveland, Ohio.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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MiralaxTM combined with Gatorade GTM given the day prior to colonoscopy is a safe, tolerable and efficacious cleansing regimen for colonoscopy in children.
Time Frame: Immediate
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Immediate
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CCF 09-378
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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