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

F

Federico II University

Status

Completed

Conditions

Cow's Milk Allergy

Treatments

Dietary Supplement: Aminoacid based formula
Dietary Supplement: Hydrolyzed whey formula

Study type

Observational

Funder types

Other

Identifiers

NCT02379598
202/2011

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

5 to 12 months old

Volunteers

No Healthy Volunteers

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

Trial design

50 participants in 2 patient groups

Amino acid based formula
Treatment:
Dietary Supplement: Aminoacid based formula
Whey protein formula
Treatment:
Dietary Supplement: Hydrolyzed whey formula

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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