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

Completed

• Conditions: Cow's Milk Allergy
• Interventions: Dietary Supplement: Hydrolyzed whey formula; Dietary Supplement: Aminoacid based formula

• Registration Number: NCT02379598
• Lead Sponsor: Federico II University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2014-05
• Study Completion: 2014-12
• Status Verified: 2015-02
• Study First Submitted: 2015-02-23
• Study First Submitted QC: 2015-02-27
• Last Update Submitted: 2015-02-27
• Study First Posted: 2015-03-05
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Whey protein formula	Hydrolyzed whey formula	-
Amino acid based formula	Aminoacid based formula	-

Primary Outcome Measures

Name	Time	Method
change of z-score weight at 12 months	after 12 months of intervention

Secondary Outcome Measures

Name	Time	Method
change of body mass index at 12 months	after 12 months of intervention

Trial Locations

Locations (1)

university of naples federico II; 🇮🇹 Naples, Italy