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

Cow's Milk Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379598
• Other study ID #: 202/2011
• Status: Completed
• Phase: N/A
• First received: February 23, 2015
• Last updated: February 27, 2015
• Start date: May 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Commitee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Months to 12 Months

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cow's Milk Allergy
• Hypersensitivity
• Milk Hypersensitivity

Intervention

Dietary Supplement:
• Aminoacid based formula
Formula based on aminoacid
• Hydrolyzed whey formula
Formula based on hydrolyzed whey protein

Locations

Country	Name	City	State
Italy	university of naples federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of z-score weight at 12 months		after 12 months of intervention	No
Secondary	change of body mass index at 12 months		after 12 months of intervention	No