The Journey of Children With Cow's Milk Protein Allergy in Mexico.

Cow's Milk Protein Allergy Clinical Trial

— Friso02  

Official title:

A Retrospective and Comparative Study on the Journey of Children With Cow´s Milk Protein Allergy in Mexico: Current Practice in Allergy Management in Mexican Children Aged ≤24 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04596059
• Other study ID #: CEI00320171130/07/052020
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: August 2021
• Source: FrieslandCampina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To gain insights on the application, use and effectiveness of Frisolac Gold Intensive HA and Frisolac Gold PEP AC with reference to improvement of CMPA symptoms and to determine the methodology used by Mexican Health Care Professionals (HCPs) in the clinical practice (i.e. diagnosis and dietary management) of CMPA in Mexican children (≤24 months) diagnosed with or suspected of CMPA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cow's Milk Protein Allergy
• Food Hypersensitivity
• Hypersensitivity
• Milk Hypersensitivity

Intervention

Other:
• Frisolac Gold Intensive HA
Regular medical care

Locations

Country	Name	City	State
Mexico	Clinica San Antonio	Mexico City
Mexico	Clínica de Alergia Pediátrica	Pachuca
Mexico	Consultorio de Pediatria	Pachuca
Mexico	Hospital del Niño DIF	Pachuca

Sponsors (2)

Lead Sponsor	Collaborator
FrieslandCampina	Sprim Advanced Life Sciences

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth	the proportion of subjects with weight gain compared to the previous visit (%); the proportion of subjects with height gain compared to the previous visit (%); the proportion of subjects with both weight and height gain compared to the previous visit (%)	Can be 2 weeks up to 2 months
Primary	Dermatological symptoms (SCORAD score)	The proportion of subjects with an 1-point improvement in their SCORAD intensity category in between 2 visits (%)	Can be 2 weeks up to 2 months
Secondary	Type of symptoms	Type of symptoms (e.g. crying, regurgitation, stool consistency, respiratory, enteropathies and colitis) (based on clinical diagnosis)	Can be 2 weeks up to 2 months
Secondary	Number of symptoms	Number of symptoms (e.g. crying, regurgitation, stool consistency, respiratory, enteropathies and colitis) (based on clinical diagnosis)	Can be 2 weeks up to 2 months
Secondary	Severity of symptoms	Severity of symptoms on first and second visit (based on clinical diagnosis)	Can be 2 weeks up to 2 months