Effect of Therapy With Aminoacid Based Formula Versus Hydrolyzed Whey Proteins in Children With Cow's Milk Allergy
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|ClinicalTrials.gov Identifier: NCT02379598|
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : March 5, 2015
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.
|Condition or disease||Intervention/treatment|
|Cow's Milk Allergy||Dietary Supplement: Aminoacid based formula Dietary Supplement: Hydrolyzed whey formula|
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||Effect of Therapy With Aminoacid Based Formula Versus Hydrolyzed Whey Proteins in Children With Cow's Milk Allergy|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||December 2014|
|Amino acid based formula||
Dietary Supplement: Aminoacid based formula
Formula based on aminoacid
|Whey protein formula||
Dietary Supplement: Hydrolyzed whey formula
Formula based on hydrolyzed whey protein
- change of z-score weight at 12 months [ Time Frame: after 12 months of intervention ]
- change of body mass index at 12 months [ Time Frame: after 12 months of intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02379598
|university of naples federico II|
|Naples, Italy, 80131|