Effect of Therapy With Aminoacid Based Formula Versus Hydrolyzed Whey Proteins in Children With Cow's Milk Allergy
Information source: Federico II University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cow's Milk Allergy
Intervention: Aminoacid based formula (Dietary Supplement); Hydrolyzed whey formula (Dietary Supplement)
Phase: N/A
Status: Completed
Sponsored by: Federico II University
Summary
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.
Clinical Details
Official title: Effect of Therapy With Aminoacid Based Formula Versus Hydrolyzed Whey Proteins in Children With Cow's Milk Allergy
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: change of z-score weight at 12 months
Secondary outcome: change of body mass index at 12 months
Eligibility
Minimum age: 5 Months.
Maximum age: 12 Months.
Gender(s): Both.
Criteria:
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
Locations and Contacts
university of naples federico II, Naples 80131, Italy
Additional Information
Starting date: May 2012
Last updated: February 27, 2015
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