The Journey of Children With Cow's Milk Protein Allergy in Mexico. (Friso02)

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

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.

Study Overview

• Status: Completed
• Conditions: Cow's Milk Protein Allergy
• Intervention / Treatment: Other: Frisolac Gold Intensive HA

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico
    • Clínica San Antonio
  • Pachuca, Mexico
    • Clínica de Alergia Pediátrica
  • Pachuca, Mexico
    • Consultorio de Pediatria
  • Pachuca, Mexico
    • Hospital del Niño DIF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Mexican children (≤24 months) diagnosed with or suspected of CMPA.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Severity of symptoms	Severity of symptoms on first and second visit (based on clinical diagnosis)	Can be 2 weeks up to 2 months

Collaborators and Investigators

• Sponsor: FrieslandCampina
• Collaborators: Sprim Advanced Life Sciences
• Investigators: Principal Investigator: Rosa E Huerta Hernandez, MD, Clínica de Alergia Pediátrica, México; Principal Investigator: Benjamin Zepeda Ortega, MD, Clinica San Antonio, Mexico; Principal Investigator: Marlene Ruiz Castillo, MD, Hospital del Niño DIF Hildago, Mexico; Consultorio de Pediatría Pachuca, Mexico

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 26, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: CEI00320171130/07/052020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No