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

NCT02379598 | Completed

• 1 other identifier: 202/2011
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• change of z-score weight at 12 months

  after 12 months of intervention

Secondary Outcomes (1)

• change of body mass index at 12 months

  after 12 months of intervention

Study Arms (2)

Amino acid based formula

Dietary Supplement: Aminoacid based formula

Whey protein formula

Dietary Supplement: Hydrolyzed whey formula

Interventions

Aminoacid based formula DIETARY_SUPPLEMENT

Formula based on aminoacid

Amino acid based formula

Hydrolyzed whey formula DIETARY_SUPPLEMENT

Formula based on hydrolyzed whey protein

Whey protein formula

Eligibility Criteria

• Age: 5 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children with a sure diagnosis of cow's milk allergy

You may qualify if:

• subjects with diagnosis of cow's milk allergy

You may not qualify if:

• age \<5 months
• age \>12 months
• other concomitant chronic diseases
• malformations
• other food allergies

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

university of naples federico II

Naples, Naples, 80131, Italy

Location

Related Publications (1)

• 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.

  PMID: 27437928 DERIVED

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: March 5, 2015
• Study Start: May 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 5, 2015

Record last verified: 2015-02

Locations

IT (1)