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OpenTrials
Completed

NCT Number: NCT02351531

Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy

The aim of the study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula.

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Key information

Conditions

Cow Milk Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier Régional, Namur, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • between 1 and 12 months old
  • having a cow milk allergy confirmed by a positive double-blind food challenge performed in the last 3 months,
  • whose parent(s) signed the informed consent form

Exclusion criteria

  • Infants mainly or exclusively breastfed,
  • Infants having a weight at inclusion < 2500g,
  • Infants who refused to drink an extensively hydrolyzed formula anytime prior to inclusion,
  • Infants fed an amino acid based formula
  • Infants who had an anaphylactic reaction in the past,

Treatment and study plan

Extensively Hydrolyzed formula

Dietary Supplement

Primary outcomes

  1. Number of patients dropped out for intolerance

    Time frame: 2 weeks

Secondary outcomes

  1. Cow's milk protein hypersensitivity score

    Time frame: 2 weeks

  2. Growth (weight, height, head circumference)

    Time frame: 3 months

  3. Growth (weight, height, head circumference)

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

United Pharmaceuticals

Industry

Registry information

Acronym: COMETE

Important dates

Study start
2013
Primary completion
2014
First posted
Jan 30, 2015
Registry last updated
Jan 30, 2015

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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