Cow's Milk Allergy Clinical Trial
Official title:
Oral Immunotherapy in Cow's Milk Allergy (CMA) in Children : "Petit Lait" Study
Prospective study Main objective: to evaluate the efficiency and the security of two
protocols of immunotherapy (raw milk versus heated milk) in a cohort of children with
persistent Immunoglobulin E (IgE) mediated CMA (IgE-CMA).
Secondary objectives: to determinate if the enumeration of casein-specific IL-4- and
IL-13-secreting T cells could be a valuable biomarker of successful immunotherapy.
The study prospectively included children aged older than 3 years, with an IgE-CMA.
Children were part of the " Petit Lait " Study, led from June 2012 in the Allergology
Department of Armand Trousseau Children's Hospital, "Assistance Publique-Hôpitaux de Paris
(AP-HP)", France
1. Inclusion criteria All the children presenting with a diagnosis of IgE- CMA(defined as
a history of reaction to the ingestion of cow's milk product and positive skin prick
test (wheal ≥3 mm to cow's milk with no reaction to the negative control and specific
IgE to casein >0.35 (kiloUnit) kU/l) and referred to one of the Allergology Department
were offered to enter the study.
Double-blind, placebo-controlled (DBPCFC) oral food challenge The DBPCFC was performed
outside of episodes of exacerbation of acute illness. Children were admitted to the
allergy clinic on two separate days, and food challenges were performed under the
supervision of an experienced allergist. A peripheral intravenous line was inserted in
each patient before starting the challenge, according to recommendations.Increasing
doses of cow's milk were administered 20 min apart. Two protocols were available, one
called " standard protocol " and one called "hyperallergic protocol". Type of protocol
was chosen before inclusion through a multidisciplinar and collegial manner. Challenge
was stopped in case of a clinical reaction compatible with an allergic reaction.
Antihistamine, methylprednisolone, bronchodilator or epinephrine was administered if
necessary. Cumulative dose of cow's milk tolerated defined the reactive threshold in
CMA children.
2. Exclusion criteria Children who have presented an anaphylactic reaction during the
previously year, who reacted with placebo during the DBPCFC or those with lacking
consent or parents having difficulties to understand the protocol were excluded from
the study.
3. Oral Immunotherapy Phase Children were assigned by randomization to raw milk
immunotherapy or heated milk immunotherapy.
4. Prospective follow-up A monthly call was performed by a medical staff trained to
allergology and families were asked on milk dose daily ingested at home and on eventual
adverse side effects. A final DBPCFC using the standard protocol was planned once the
daily dose attained 80 mL of raw milk.
5. Biological markers
- Measurement of IgE and Immunoglobulin G4 (IgG4) against casein
- Measurement of Interleukin 4 (IL4) and Interleukin 13 (IL13) secreting lymphocyts
by an Enzym Link ImmunoSpot (ELISpot) assay to cow's milk protein
;
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