Sublingual Milk Immunotherapy in Children
Summary
Sublingual immunotherapy is developing in the treatment of aeroallergens allergy. The hypothesis is that such process may be applied to food allergy, more precisely to milk. A previous series of 8 patients indicates the likely effectiveness of this technique (Allergy, 2006).
Description
National study of current practice, multicentric, randomized, open All oral provocation tests will be randomized, double blind Study treatment. For oral provocation test, placebo with NeocatePasteurized half skimmed milk (available in standard outlets) from 0.1 to 0.8 mL/day Tests At M0 :1) Clinical examination 2) Biological test (blood sample 16.5 mL) : WBC, ferritin, total IgE, specific IgE, cow milk, ALPHALACTALBUMIN , casein, BETALACTOGLOBULIN and goat milk using RASTSpecific secretory IgA by ESPCI (frozen saliva)Biologic collection- Specific immunoglobulins against cow' milk, ALPHALACTALBUMIN, casein, BETALACTOGLOBULIN, quantification of IgM, sub classes of IgG and IgA by ESPCI (frozen serum).
Analysis of minor allergens by immunoblot 2 D, ESPCI (frozen serum)3) prick tests 4) 1 or 2 oral provocation test (TPO) double blind, during 2 days At M3 : clinical examination, side effects during the 3 preceding months At M6 :1) Clinical examination 2) Biological test (blood sample 16.5 mL) : WBC, ferritin, total IgE, specific IgE, cow milk, ALPHALACTALBUMIN, casein, BETALACTOGLOBULIN and goat milk using RAST Specific secretory IgA by ESPCI (frozen saliva)Biologic collection Specific immunoglobulins against cow' milk, ALPHALACTALBUMIN, casein, BETALACTOGLOBULIN, quantification of IgM, sub classes of IgG and IgA by ESPCI (frozen serum).
Analysis of minor allergens by immunoblot 2 D, ESPCI (frozen serum)3) prick tests 4) 1 or 2 oral provocation test (TPO) double blind, during 2 days At M12 :1) Clinical examination2) Biological test (blood sample 16.5 mL) : WBC, ferritin, total IgE, specific IgE, cow milk, ALPHALACTALBUMIN, casein, BETALACTOGLOBULIN and goat milk using RAST Specific secretory IgA by ESPCI (frozen saliva)Biologic collection- Specific immunoglobulins against cow' milk, ALPHALACTALBUMIN, casein, BETALACTOGLOBULIN , quantification of IgM, sub classes of IgG and IgA by ESPCI (frozen serum).
Analysis of minor allergens by immunoblot 2 D, ESPCI (frozen serum)3) prick tests 4) 1 or 2 oral provocation test (TPO) double blind, during 2 days
Study Design
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Cow Milk Allergy
Intervention
Milk, Milk
Location
Hospital Cochin - Saint-Vincent de Paul
Paris
France
75679
Status
Active, not recruiting
Source
Assistance Publique - Hôpitaux de Paris
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00874627
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Milk Hypersensitivity
Allergic reaction to milk (usually cow's milk) or milk products. MILK HYPERSENSITIVITY should be differentiated from LACTOSE INTOLERANCE, an intolerance to milk as a result of congenital deficiency of lactase.
Lactation
The processes of milk secretion by the maternal MAMMARY GLANDS after PARTURITION. The proliferation of the mammary glandular tissue, milk synthesis, and milk expulsion or let down are regulated by the interactions of several hormones including ESTRADIOL; PROGESTERONE; PROLACTIN; and OXYTOCIN.
Milk Ejection
Expulsion of milk from the mammary alveolar lumen, which is surrounded by a layer of milk-secreting EPITHELIAL CELLS and a network of myoepithelial cells. Contraction of the myoepithelial cells is regulated by neuroendocrine signals.
Milk Proteins
The major protein constituents of milk are CASEINS and whey proteins such as LACTALBUMIN and LACTOGLOBULINS. IMMUNOGLOBULINS occur in high concentrations in COLOSTRUM and in relatively lower concentrations in milk. (Singleton and Sainsbury, Dictionary of Microbiology and Molecular Biology, 2d ed, p554)
Milk Banks
Centers for acquiring, storing, and distributing human milk.
Clinical Trials
The purpose of this study is to determine if small oral doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.
The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy
The purpose of this study is to determine if small oral and sublingual doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.
OIT and Xolair® (Omalizumab) in Cow's Milk Allergy
Food allergy affects up to 4% of the U.S. population and is most common in young children. Milk allergy is the most common cause of food allergy in infants and young children, and usually...
An Interventional Study of Milk Allergy and Tolerance in Children
Milk is among the most common food allergens in infants and children. The majority of children outgrow their milk allergies; however, the exact mechanisms by which food tolerance is achiev...
Cow's Milk Allergy in Infants With Obstructive Sleep Apnea (OSA)
Cow's milk allergy may be involved in the evolution of sleep apnea in infants. The study will assess the effects of specifies diet changes (i.e. non-milk based formula) on the infant. Spe...
PubMed Articles
Milk processing as a tool to reduce cow's milk allergenicity: a mini-review.
Milk processing technologies for the control of cow's milk protein allergens are reviewed in this paper. Cow's milk is a high nutritious food; however, it is also one of the most common food allergens...
Allergenicity of casein containing chalk in milk allergic schoolchildren.
Nondietary exposure to milk proteins may be a risk for children who do not outgrow milk allergy by school age.
In this study, it was aimed to determine organochlorine pesticides (OCPs) in three types of milk (cow's, buffalo's, and sheep's milk) produced in Afyonkarahisar province of Turkey. The results indicat...
Risk behaviours for milk-borne diseases transmission along the milk chain in The Gambia and Senegal.
The objective of this study was the characterisation of the traditional milk chain in Western Region (The Gambia) and Kolda (Southern Senegal); and the analysis of milk chain actors' risk behaviours f...
The aim of this study was to investigate the adulteration of goat milk produced by smallholders in semiarid northeastern Brazil with bovine milk as an adulterant. The study was requested by the associ...
