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

NCT ID: NCT02379598

Last Updated: 2015-03-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2014-12-31

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.

Conditions

Cow's Milk Allergy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Amino acid based formula

Aminoacid based formula

Intervention Type: DIETARY_SUPPLEMENT

Formula based on aminoacid

Whey protein formula

Hydrolyzed whey formula

Intervention Type: DIETARY_SUPPLEMENT

Formula based on hydrolyzed whey protein

Interventions

Aminoacid based formula

Formula based on aminoacid

Intervention Type: DIETARY_SUPPLEMENT

Hydrolyzed whey formula

Formula based on hydrolyzed whey protein

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 5 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Roberto Berni Canani

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

university of naples federico II

Naples, Naples, Italy

Countries

Italy

References

Canani RB, Nocerino R, Frediani T, Lucarelli S, Di Scala C, Varin E, Leone L, Muraro A, Agostoni C. Amino Acid-based Formula in Cow's Milk Allergy: Long-term Effects on Body Growth and Protein Metabolism. J Pediatr Gastroenterol Nutr. 2017 Apr;64(4):632-638. doi: 10.1097/MPG.0000000000001337.

Reference Type: DERIVED

PMID: 27437928 (View on PubMed)

Other Identifiers

202/2011

Identifier Type: -

Identifier Source: org_study_id