Cow's Milk Allergy Clinical Trial
Official title:
Tolerance to a New Free Amino Acid-based Formula in Children With IgE or Non-IgE-mediated Cow's Milk Allergy
Verified date | June 2012 |
Source | Federico II University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
The investigators aim to assess the tolerance to a new commercially available Aaf in children affected by IgE- or non-IgE-mediated CMA.
Status | Completed |
Enrollment | 60 |
Est. completion date | October 2011 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month to 168 Months |
Eligibility |
Inclusion Criteria: - Pediatric patients (=14 years of age) with a recent diagnosis of IgE- or non-IgE-mediated CMA, confirmed by positive DBPCFC or anaphylaxis in the 2 months prior to enrollment and under good clinical control. Exclusion Criteria: - Children with 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 - Gastroesophageal reflux disease non-food allergy-related - Suspected eosinophilic gastrointestinal disorders, were excluded. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | University of Naples Federico II | Naples |
Lead Sponsor | Collaborator |
---|---|
Federico II University |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tolerance to a new free amino acid-based formula in children with IgE or non-IgE-mediated cow's milk allergy | Consecutive patients affected by IgE- or non-IgE-mediated CMA, aged = 14 years, were enrolled. Oral food challenge was carried out with increasing doses of the new Aaf (Sineall, Humana, Milan, Italy), using validated Aaf as placebo. Fecal concentrations of calprotectin (FC) and eosinophilic cationic protein (ECP) were monitored. | about 2 year | Yes |
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