Status:

COMPLETED

Cow's Milk Allergy and Functional Gastrointestinal Disorders

Lead Sponsor:

Federico II University

Conditions:

Cow's Milk Allergy

Functional Gastrointestinal Disorders

Eligibility:

All Genders

4-6 years

Brief Summary

Cow's milk allergy (CMA) is the most common food allergy in early childhood, with an estimated incidence ranging between 2% and 3% in infants and marginally lower in older children. It has been demons...

Eligibility Criteria

Inclusion

  • Children (aged from 4 to 6 yrs) with a history of sure diagnosis of cow's milk allergy obtained in the first year of life treated with hypoallergenic formula

Exclusion

  • Age higher than 12 months,
  • concomitant chronic systemic diseases,
  • congenital cardiac defects,
  • active tuberculosis,
  • autoimmune diseases,
  • immunodeficiency,
  • chronic inflammatory bowel diseases,
  • celiac disease,
  • cystic fibrosis,
  • metabolic diseases,
  • malignancy,
  • chronic pulmonary diseases,
  • malformations of the gastrointestinal tract,
  • suspected eosinophilic esophagitis or eosinophilic enterocolitis,
  • suspected food-protein-induced enterocolitis syndrome,
  • suspected cow's milk proteins-induced anaphylaxis.

Key Trial Info

Start Date :

February 1 2013

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 1 2014

Estimated Enrollment :

220 Patients enrolled

Trial Details

Trial ID

NCT01901380

Start Date

February 1 2013

End Date

August 1 2014

Last Update

July 31 2017

Active Locations (1)

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1

University of Naples Federico II

Naples, Italy, 80131