Effects of Different Dietary Regimens on Tolerance Acquisition in Children With Cow's Milk Allergy

Completed

• Conditions: Cow's Milk Allergy

• Registration Number: NCT01634490
• Lead Sponsor: Federico II University

Brief Summary

Otherwise healthy infants (1-12 months of age at the diagnosis) with CMA were prospectively evaluated. Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded. A food challenge was performed 6 and 12 months after the diagnosis to assess clinical tolerance acquisition. Main demographic and clinical characteristics were collected for each patient.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-07
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-05
• Last Update Submitted: 2012-07-05
• Study First Posted: 2012-07-06
• Last Update Posted: 2012-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Otherwise healthy infants (1-12 months of age at the diagnosis) with cow's milk allergy were prospectively evaluated

Exclusion Criteria

• Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the effect of different dietotherapeutic approaches on the time of tolerance acquisition in children with cow's milk allergy	about 4 year	. Otherwise healthy infants (1-12 months of age at the diagnosis) with CMA were prospectively evaluated. Patients with cow's milk protein-induced anaphylaxis, eosinophilic disorders of the gastrointestinal tract, and food protein induced enterocolitic syndrome were excluded. A food challenge was performed 6 and 12 months after the diagnosis to assess clinical tolerance acquisition. Main demographic and clinical characteristics were collected for each patient.