Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT05424757
Brief 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)
Study:
NCT05424757
Study Brief:
Protocol Section:
NCT05424757