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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02379598
Enrollment
50
Registered
2015-03-05
Start date
2012-05-31
Completion date
2014-12-31
Last updated
2015-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cow's Milk Allergy

Brief 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.

Interventions

DIETARY_SUPPLEMENTAminoacid based formula

Formula based on aminoacid

DIETARY_SUPPLEMENTHydrolyzed whey formula

Formula based on hydrolyzed whey protein

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Months to 12 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
change of z-score weight at 12 monthsafter 12 months of intervention

Secondary

MeasureTime frame
change of body mass index at 12 monthsafter 12 months of intervention

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026