Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT04596059
Eligibility Criteria:
Inclusion Criteria:
* Subjects with electronic/physical medical records that contain sufficient data to answer the primary question (i.e. data on growth and dermatological symptoms (based on the SCORAD score) at diagnosis and follow up data of at least 2 months or successful completion of therapy according to the PI (whichever comes first).
* Subjects ≤24 months of age at the moment of suspected or diagnosed CMPA with records available between January 2016 to September 2020.
* Subjects prescribed with Frisolac Gold Intensive HA and/or Frisolac Gold PEP AC for the dietary management of their CMPA symptoms.
Exclusion Criteria:
* Subjects using other formula products/breast milk alongside Frisolac Gold Intensive HA or Frisolac Gold PEP AC during the time of their participation in the study.
* Premature children, or children with low birth-weight (weight at birth \<2.5 kg).
* Subjects diagnosed with a metabolic condition that impacts development and growth.
* Subjects diagnosed with a congenital condition and/or with prior or current disease that in the opinion of the PI could potentially interfere with their participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Months
Maximum Age:
24 Months
Study:
NCT04596059
Study Brief:
Protocol Section:
NCT04596059