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

NCT02465905 | Completed

• 1 other identifier: 2012-A00641-42
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cow's Milk Allergy

Outcome Measures

Primary Outcomes (2)

• Clinical Outcome: increased tolerance to cow's milk

  daily unit dose in milliliters of milk ingested

  12 months

• 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 Outcomes (4)

• Biological Outcome: kinetics of specific IgE against casein

  12 months

• Biological Outcome: kinetics of specific IgG4 against casein

  12 months

• Biological Outcome: kinetics of IL4 secreting lymphocytes against casein

  12 months

• Biological Outcome: kinetics of IL13 secreting lymphocytes against casein

  12 months

Study Arms (2)

Raw milk

ACTIVE COMPARATOR

For raw milk immunotherapy (RMI), fixed dose of raw milk was daily administered at home, determined using tolerated threshold dose during the DBPCFC. Augmentation was made every 5 weeks in the allergy clinic.

Other: raw milk

Heated milk

ACTIVE COMPARATOR

For heated milk immunotherapy (HMI), families were asked to weekly increase the daily dose of milk at home using industrial preparations. Milk included in the preparation was less and less heated among time. Passage from heated-milk to half-heated milk and then raw milk was performed in the allergy clinic.

Other: Heated milk

Interventions

raw milk OTHER

Raw milk

Heated milk OTHER

Heated milk

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Flore AMAT: lead

Study Sites (1)

Service d'Allergologie

Paris, 75012, France

Location

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 9, 2015
• Study Start: June 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: April 17, 2017

Record last verified: 2017-04

Locations

FR (1)