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

Cow's Milk Allergy Clinical Trial

— Petit Lait  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02465905
• Other study ID #: 2012-A00641-42
• Status: Completed
• Phase: N/A
• First received: June 2, 2015
• Last updated: April 13, 2017
• Start date: June 2012
• Est. completion date: May 2016

Study information

• Verified date: April 2017
• Source: Association Poumon et Enfance
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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 kU/l)

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

Related Conditions & MeSH terms

• Cow's Milk Allergy
• Hypersensitivity
• Milk Hypersensitivity

Intervention

Other:
• raw milk

• Heated milk

Locations

Country	Name	City	State
France	Service d'Allergologie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Dr Flore AMAT

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Outcome: increased tolerance to cow's milk	daily unit dose in milliliters of milk ingested	12 months
Primary	Clinical Outcome: occurrence of allergic reaction to cow's milk	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	12 months
Secondary	Biological Outcome: kinetics of specific IgE against casein	changes in blood level of specific IgE against casein	12 months
Secondary	Biological Outcome: kinetics of specific IgG4 against casein	changes in blood level of specific IgG4 against casein	12 months
Secondary	Biological Outcome: kinetics of IL4 secreting lymphocytes against casein	ELISPOT assay	12 months
Secondary	Biological Outcome: kinetics of IL13 secreting lymphocytes against casein	ELISPOT assay	12 months