Clinical Trial: Oral Immunotherapy in Cow's Milk Allergy (CMA) in Children : "Petit Lait" Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Oral Immunotherapy in Cow's Milk Allergy (CMA) in Children : "Petit Lait" Study

Brief Summary:

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.


Detailed Summary:

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 Childre
    Sponsor: Dr Flore AMAT

    Current Primary Outcome:

    • Clinical Outcome: increased tolerance to cow's milk [ Time Frame: 12 months ]
      daily unit dose in milliliters of milk ingested
    • Clinical Outcome: occurrence of allergic reaction to cow's milk [ Time Frame: 12 months ]
      Number of patients with occurrence of allergic reaction; if yes, severity of allergic reaction evaluated using: Astier score; number of use of rescue medications such as: bronchodilator, anti-histaminics, systemic corticosteroids, epinephrin


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Biological Outcome: kinetics of specific IgE against casein [ Time Frame: 12 months ]
      changes in blood level of specific IgE against casein
    • Biological Outcome: kinetics of specific IgG4 against casein [ Time Frame: 12 months ]
      changes in blood level of specific IgG4 against casein
    • Biological Outcome: kinetics of IL4 secreting lymphocytes against casein [ Time Frame: 12 months ]
      ELISPOT assay
    • Biological Outcome: kinetics of IL13 secreting lymphocytes against casein [ Time Frame: 12 months ]
      ELISPOT assay


    Original Secondary Outcome: Same as current

    Information By: Association Poumon et Enfance

    Dates:
    Date Received: June 2, 2015
    Date Started: June 2012
    Date Completion:
    Last Updated: April 13, 2017
    Last Verified: April 2017