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NCT01164410 · ClinicalTrials.gov registry record
The Efficacy Side Effects and the Tolerance of Polyethylene Glycol 3350 as a Bowel Prep in Children
A clinical trial, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- 45
- Enrollment target
NCT01164410: Completed study, sponsored by The Cleveland Clinic.
NCT01164410 is a clinical trial that has completed, run by The Cleveland Clinic. The registered enrollment target is 45 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01164410 has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- 45 participants
- Enrollment target
Study Summary
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 t
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-06 |
What the finished NCT01164410 record still lists
NCT01164410 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 45 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01164410 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01164410 about?
NCT01164410 is a clinical study titled "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 pa...
What is the current status of trial NCT01164410?
This trial is currently completed. The enrollment target is 45 participants. The study started on 2009-08. Estimated completion is 2010-06.
Who is sponsoring clinical trial NCT01164410?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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