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OpenTrials
Completed

NCT Number: NCT02379598

Effect of Therapy With Aminoacid Based Formula Versus Hydrolyzed Whey Proteins in Children With Cow's Milk Allergy

Cow's milk allergy is an immunologically mediated adverse reaction to milk proteins. In industrialized countries there is an incidence of 2-3% in children younger than 2 years. Cow's milk allergy may present with different clinical pictures and symptoms often nonspecific. Among the most common are certainly food refusal and failure to thrive until frameworks frank malnutrition. It was also noted that the cow's milk allergy can have a negative impact on the quality of life of the patient and his family.

The treatment of this condition provides the setting of a diet that is free of the allergen to the base of the adverse reaction.

There are some types of formulas for the treatment of this condition. The formulas based on amino acids are currently used in all cases non-responsive to treatment with the above formulas or in all those characterized by severe allergic reactions. Being made from amino acids such formulas are by definition non-allergenic. They have also proven to ensure a rapid resolution of symptoms favoring a resumption of growth, nutritional status, as well as lead to a rapid improvement in the quality of life of the patient and his family. However, the studies currently available to us concerning the effects of nutritional formulas based on amino acids affect short observation periods (usually less than 6 months) and were directed to a comparison only with hydrolysates of whey protein or casein and not with healthy subjects. To date thus lack consistent data on the nutritional effects in the medium to long term.

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Key information

Age range

5 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

university of naples federico II

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • subjects with diagnosis of cow's milk allergy

Exclusion criteria

  • age <5 months
  • age >12 months
  • other concomitant chronic diseases
  • malformations
  • other food allergies

Treatment and study plan

Aminoacid based formula

Dietary Supplement

Formula based on aminoacid

Hydrolyzed whey formula

Dietary Supplement

Formula based on hydrolyzed whey protein

Primary outcomes

  1. change of z-score weight at 12 months

    Time frame: after 12 months of intervention

Secondary outcomes

  1. change of body mass index at 12 months

    Time frame: after 12 months of intervention

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 5, 2015
Registry last updated
Mar 5, 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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