Polyethylene Glycol Safety in Children
NCT05424757 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 158
Last updated 2025-11-04
Summary
The primary objective is to measure levels of selected PEG 3350 components and metabolites in the blood and urine of children who are already taking PEG 3350 compared to children who are not taking PEG 3350.
Changes to medical therapy are not recommended as part of this study.
Conditions
- Polyethylene Glycols
- Children, Only
Interventions
- DRUG
-
PEG 3350
Data and biospecimens will be collected from two groups of children: * Children who have taken PEG 3350 daily for at least 30 days. * Children who have NOT taken PEG 3350 for at least 30 days. No changes to medicines are recommended as part of this study.
Sponsors & Collaborators
-
Food and Drug Administration (FDA)
collaborator FED -
Children's Hospital of Philadelphia
lead OTHER
Principal Investigators
-
Robert O Heuckeroth, MD, PhD · Children's Hospital of Philadelphia
Eligibility
- Min Age
- 0 Years
- Max Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-09-30
- Primary Completion
- 2025-08-09
- Completion
- 2025-08-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
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