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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02379598
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : March 5, 2015
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, 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.


Condition or disease Intervention/treatment
Cow's Milk Allergy Dietary Supplement: Aminoacid based formula Dietary Supplement: Hydrolyzed whey formula

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. change of z-score weight at 12 months [ Time Frame: after 12 months of intervention ]

Secondary Outcome Measures :
  1. change of body mass index at 12 months [ Time Frame: after 12 months of intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with a sure diagnosis of cow's milk allergy
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

Information from the National Library of Medicine

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


Locations
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Italy
university of naples federico II
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Roberto Berni Canani, MD, PhD, Federico II University
ClinicalTrials.gov Identifier: NCT02379598    
Other Study ID Numbers: 202/2011
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate