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OpenTrials
Completed

NCT Number: NCT04596059

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

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.

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Key information

Conditions

Cow's Milk Protein Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

0 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica San Antonio, Mexico City, Mexico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Frisolac Gold Intensive HA

Other

Regular medical care

Other names: Frisolac Gold PEP AC

Primary outcomes

  1. Growth

    Time frame: Can be 2 weeks up to 2 months

    • 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 (%)

  2. Dermatological symptoms (SCORAD score)

    Time frame: Can be 2 weeks up to 2 months

    The proportion of subjects with an 1-point improvement in their SCORAD intensity category in between 2 visits (%)

Secondary outcomes

  1. Type of symptoms

    Time frame: Can be 2 weeks up to 2 months

    Type of symptoms (e.g. crying, regurgitation, stool consistency, respiratory, enteropathies and colitis) (based on clinical diagnosis)

  2. Number of symptoms

    Time frame: Can be 2 weeks up to 2 months

    Number of symptoms (e.g. crying, regurgitation, stool consistency, respiratory, enteropathies and colitis) (based on clinical diagnosis)

  3. Severity of symptoms

    Time frame: Can be 2 weeks up to 2 months

    Severity of symptoms on first and second visit (based on clinical diagnosis)

Sponsors and collaborators

Lead sponsor

FrieslandCampina

Industry

Collaborators

  • Sprim Advanced Life Sciences

Registry information

Official study 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

Acronym: Friso02

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 22, 2020
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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