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Hypoallergenicity To Substitutive Formulas 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. Identifier: NCT02144428
Recruitment Status : Unknown
Verified May 2014 by Roberto Berni Canani, Federico II University.
Recruitment status was:  Recruiting
First Posted : May 22, 2014
Last Update Posted : May 22, 2014
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University

Brief Summary:
The management of children with confirmed cow's milk allergy is based on complete avoidance of cow's milk proteins and leaves the physician with several dietary options, none of which, given the prevalence, spectrum and potential seriousness of the condition, can be recommended to all patients. In the absence of an alternative to cow's milk, the management of cow's milk allergy is based on the use of safe, affordable and nutritionally adequate formulas. Extensively hydrolyzed cow's milk protein formulas, which are considered as safe for most children with cow's milk allergy, are still liable to contain residual peptides, and hypersensitivity reactions may occur in infants allergic to cow's milk protein. Thus, specific product allergenicity must be addressed on an individual basis before recommending a formula as a substitute for cow's milk. Soy-based formula can also concomitant sensitize cow's milk allergy children to soy. Amino acid-based formulas have been studied from safety and nutritional efficacy perspectives. These formulas have been proposed for subjects highly sensitive to cow's milk protein and that cannot be managed using extensively hydolyzed formula and for children with multiple food allergies. In these conditions aminoacid based formulas are able to effectively cure allergic symptoms and to improve body growth.

Condition or disease
Cow's Milk Allergy

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : April 2011
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Cow's milk allergy
Subjcets with a sure diagnosis of cow'a milk allergy on exclusion diet

Primary Outcome Measures :
  1. Number of subjects with cow's milk allergy tolerant substitutive formulas [ Time Frame: At diagnosis and for at least 1 months after the diagnosis ]
    Safety and tolerability of substitutive formulas

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with cow's milk allergy diagnosed by family pediatrician operating in Italy

Inclusion Criteria:

  • subjects with a cow's milk allergy
  • age between 0 to 36 months

Exclusion Criteria:

  • age more than 36 months
  • eosinophilic disorders of the gastrointestinal tract,
  • food protein induced enterocolitic syndrome,
  • concomitant chronic systemic diseases,
  • congenital cardiac defects,
  • active tuberculosis,
  • autoimmune diseases,
  • immunodeficiency,
  • chronic inflammatory bowel diseases,
  • celiac disease,
  • cystic fibrosis,
  • metabolic diseases,
  • lactose intolerance,
  • malignancy,
  • chronic pulmonary diseases,
  • malformations of the gastrointestinal tract.

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 identifier (NCT number): NCT02144428

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Contact: Roberto Berni Canani, MD, PhD 0817462680

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University of Naples Federico II Recruiting
Naples, Italy, 80131
Contact: Roberto Berni Canani    0817462680      
Sponsors and Collaborators
Federico II University

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Responsible Party: Roberto Berni Canani, MD, PhD, Federico II University Identifier: NCT02144428     History of Changes
Other Study ID Numbers: 05/14
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: May 22, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate