Pilot Study on the Efficacy and Safety of an Oral Desensitization Protocol at the Onset of Food Allergy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypersensitivity, Milk
- Sponsor
- IRCCS Burlo Garofolo
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- number of children that completed the home oral immunotherapy protocol, reaching clinical tolerance
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Cow's milk (CM) allergy is the most frequent food allergy in the first years of life, with prevalence rates estimated in the range of 2-3%.
The elimination of CM is the mainstay of treatment, but accidental exposure to CM proteins is not uncommon, with a considerable risk of severe allergic reactions.
Recent evidence suggests that early oral exposure in young children may protect to the development of allergy. On the same way, strategies have been developed for the use of oral exposure as immunotherapy for the treatment of children with established food allergy even if available data on the use of oral immunotherapy in infants with food allergy are very limited.
The aim of this study is to evaluate the feasibility of an oral immunotherapy protocol, started in the first year of life, in children with CM allergy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •children between 3-12 months with CM allergy (defined as the association of typical clinical manifestations in the first hour after CM ingestion and evidence of sensitization of CM proteins on both skin prick test and specific serum IgE levels)
Exclusion Criteria
- •children with not IgE-mediated clinical manifestations
- •children with a known immunodeficiency
Outcomes
Primary Outcomes
number of children that completed the home oral immunotherapy protocol, reaching clinical tolerance
Time Frame: 6 months
Clinical tolerance defined as the achievement of a dose of 150 ml of CM or a corresponding dose of dairy products
Secondary Outcomes
- Clinical reactions experienced by children at home(6 months)
- Serum levels of specific IgE(6 months)
- Serum levels of specific IgG4(6 months)