Tolerance to a New Free Amino Acid-based Formula in Children With IgE or Non-IgE-mediated Cow's Milk Allergy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University
ClinicalTrials.gov Identifier:
NCT01622426
First received: June 15, 2012
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

The investigators aim to assess the tolerance to a new commercially available Aaf in children affected by IgE- or non-IgE-mediated CMA.


Condition Intervention
Cow's Milk Allergy
Dietary Supplement: tolerance to a new aminoacid based formula
Dietary Supplement: Amino acid formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Tolerance to a New Free Amino Acid-based Formula in Children With IgE or Non-IgE-mediated Cow's Milk Allergy

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • Tolerance to a new free amino acid-based formula in children with IgE or non-IgE-mediated cow's milk allergy [ Time Frame: about 2 year ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 60
Study Start Date: October 2008
Study Completion Date: October 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: New formula IgE mediated testing
Children with IgE-mediated CMA performed oral food challenge with the new formula
Dietary Supplement: tolerance to a new aminoacid based formula
Every 20 minutes, successive doses (0.1, 0.3, 1, 3, 10, 30 and 100 mL) of placebo (the commercially available Aaf Neocate, Nutricia, Milan, Italy) or of the study formula (Sineall, Humana, Milan, Italy) were administered.
Other Name: Sineall
Dietary Supplement: Amino acid formula
Every 20 minutes, successive doses (0.1, 0.3, 1, 3, 10, 30 and 100 mL) of placebo (the commercially available Aaf Neocate, Nutricia, Milan, Italy) or of the study formula (Sineall, Humana, Milan, Italy) were administered.
Other Name: Sineall
Active Comparator: New formula non-IgE-mediated testing
Children with non-IgE-mediated CMA performed oral food challenge with the new formula
Dietary Supplement: tolerance to a new aminoacid based formula
Every 20 minutes, successive doses (0.1, 0.3, 1, 3, 10, 30 and 100 mL) of placebo (the commercially available Aaf Neocate, Nutricia, Milan, Italy) or of the study formula (Sineall, Humana, Milan, Italy) were administered.
Other Name: Sineall
Dietary Supplement: Amino acid formula
Every 20 minutes, successive doses (0.1, 0.3, 1, 3, 10, 30 and 100 mL) of placebo (the commercially available Aaf Neocate, Nutricia, Milan, Italy) or of the study formula (Sineall, Humana, Milan, Italy) were administered.
Other Name: Sineall

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Month to 168 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01622426

Locations
Italy
University of Naples Federico II
Naples, Italy, 80131
Sponsors and Collaborators
Federico II University
Investigators
Principal Investigator: Roberto Berni Canani, MD, PhD Federico II University
  More Information

No publications provided by Federico II University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roberto Berni Canani, MD, PhD, Federico II University
ClinicalTrials.gov Identifier: NCT01622426     History of Changes
Other Study ID Numbers: RBC-100790
Study First Received: June 15, 2012
Last Updated: June 18, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Hypersensitivity
Milk Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on October 29, 2014