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

NCT04596059 | Completed DMC

• 1 other identifier: CEI00320171130/07/052020
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Cow's Milk Protein Allergy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Type of symptoms

  Can be 2 weeks up to 2 months

• Number of symptoms

  Can be 2 weeks up to 2 months

• Severity of symptoms

  Can be 2 weeks up to 2 months

Interventions

Frisolac Gold Intensive HA OTHER

Regular medical care

Also known as: Frisolac Gold PEP AC

Eligibility Criteria

• Age: 0 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• FrieslandCampina: lead
• Sprim Advanced Life Sciences: collaborator

Study Sites (4)

Clinica San Antonio

Mexico City, Mexico

Location

Clínica de Alergia Pediátrica

Pachuca, Mexico

Location

Consultorio de Pediatria

Pachuca, Mexico

Location

Hospital del Niño DIF

Pachuca, Mexico

Location

Related Publications (1)

• Estrada Reyes E, Zepeda Ortega B, Ten Haaf D, Kudla U, Muhardi L, Hofman DL, Hageman JHJ, Huerta Hernandez RE. Symptom's resolution and growth outcome of children with cow's milk protein allergy consuming two hydrolyzed formulas: A retrospective study in Mexico. Front Allergy. 2023 Jan 30;4:1073430. doi: 10.3389/falgy.2023.1073430. eCollection 2023.

  PMID: 36793546 DERIVED

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 22, 2020
• Study Start: October 1, 2020
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: August 27, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (4)