NCT05424757

Polyethylene Glycol Safety in Children

Quantitative Analysis of Selected PEG 3350 Components and Metabolites in Children's Plasma and Urine

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 158 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 0 Years – 16 Years
• Healthy volunteers: Accepted

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.

Detailed description

For subjects taking PEG 3350, blood and urine will be collected 1.5 to 4 hours after subjects take PEG 3350. For subjects who are not taking PEG 3350, the same PEG 3350 components and metabolites will be measured in blood and urine. PEG 3350 containing medicines from study subjects will be analyzed for the same PEG 3350 components and metabolites. A stool specimen will be collected for future studies. Additional data will be obtained from: * Review of medical records. * A brief questionnaire. * Child Behavior Checklist (CBCL) from the Achenbach System of Empirically Based Assessment (for children more than 1.5 years old) * Bayley-IV Social-Emotional Scale assessment (for children less than 1.5 years old)

Conditions

• Polyethylene Glycols
• Children, Only

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-30
• Primary completion: 2025-08-09
• Completion: 2025-08-09
• First posted: 2022-06-21
• Last updated: 2025-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study