Polyethylene Glycol Safety in Children

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This study will measure components or metabolites of PEG 3350 in blood and urine from children who are already taking PEG 3350 and compare these levels to measurements of the same molecules from a group of children who are not taking PEG 3350. PEG 3350 will not be prescribed as part of this study. Participants will complete questionnaires and provide access to their medical records. The study is being conducted in collaboration with Ohio State University and the US Food and Drug Administration.

Eligibility & Criteria

IRB #:
14-011454
Study Phase:
Not Applicable
Eligible Age Range:
0 - 17 Years
Gender:
All
Study Categories:

Visit Criteria

After consent is obtained:

  • Medical records will be reviewed.
  • Blood, urine and stool will be collected from each child.
  • If you are taking PEG 3350 medication, a sample of PEG 3350 containing medicine will be collected.
  • Study specific questionnaires will be completed.
  • A few specific questions may be asked to clarify medical history or medication dosing (for example).
  • Standardized behavioral assessments will be completed.