Polyethylene Glycol Safety in Children

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This study was designed to measure components or metabolites of PEG 3350 in blood and urine from children who were already taking PEG 3350 and to compare these levels to measurements of the same molecules from a group of children who were not taking PEG 3350. PEG 3350 was not prescribed as part of this study. Participants completed questionnaires and provided access to their medical records.
Enrollment for this study has been completed. Laboratory analysis of specimens and data analysis are being conducted. This work will be submitted for publication once all analyses have been completed. When available, study results will be accessible on https://classic.clinicaltrials.gov/ct2/show/NCT05424757.

ClinicalTrials.gov Identifier

NCT05424757

View full trial information on ClinicalTrials.gov

Eligibility & Criteria

IRB #:
14-011454
Official Title:
Polyethylene Glycol Safety in Children
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.
Leader
Robert O. Heuckeroth

Robert O. Heuckeroth, MD, PhD