Skip to main content
OpenTrials
Completed

NCT Number: NCT01998074

Evaluation of the Efficacy of a New Formula in Infants With Cow's Milk Protein Allergy

The aim of the study is to show the efficacy, tolerance and nutritional adequacy of a newly developed hydrolyzed rice formula in infants with a proven cow's milk protein allergy.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Milk Hypersensitivity Food Hypersensitivity Food Intolerance Food Sensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathological Conditions, Signs and Symptoms Protein Allergy Signs and Symptoms Signs and Symptoms, Digestive

Age range

2 week–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis

Brussels, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infants between 2 weeks and 6 months old
  • In whom cow's Milk Protein Allergy has been proved by a food challenge performed during the previous month

Exclusion criteria

  • Exclusively breast fed infants
  • Preterm infants
  • Infants already fed with an extensively hydrolyzed formula with no improvement of the symptoms.
  • Infants fed an amino acid based formula
  • Infants who had an anaphylactic reaction in the past

Treatment and study plan

extensively hydrolyzed rice protein formula

Dietary Supplement

Primary outcomes

  1. Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score

    Time frame: at 4 weeks

Secondary outcomes

  1. Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score

    Time frame: at 3 months

  2. Clinical improvement of symptoms of cow's milk protein allergy, through the use of a validated score

    Time frame: at 6 months

  3. Growth (weight, height, head circumference)

    Time frame: 1 month

  4. Growth (weight, height, head circumference)

    Time frame: 3 months

  5. Growth (weight, height, head circumference)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

United Pharmaceuticals

Industry

Registry information

Official study title

Evaluation of the Efficacy of a New Extensively Hydrolyzed Formula in Infants With Cow's Milk Protein Allergy

Acronym: Paradice

Important dates

Primary completion
2013
First posted
Nov 28, 2013
Registry last updated
Nov 28, 2013

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.