Sublingual Milk Immunotherapy in Children - Full Text View

Sponsors and Collaborators:	Assistance Publique - Hôpitaux de Paris ESPCI
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00874627

Purpose

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).

Condition	Intervention
Cow Milk Allergy	Other: Milk

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Sublingual Milk Immunotherapy in Children With IgE-Mediated Cow Milk Protein Allergy

Resource links provided by NLM:

MedlinePlus related topics: Allergy

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Reactive milk dose at inclusion, at 6 months and at 12 months [ Time Frame: at inclusion, at 6 months and at 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Skin reaction at inclusion at 6 months and at 12 months [ Time Frame: at inclusion at 6 months and at 12 months ] [ Designated as safety issue: Yes ]
Specific IgE rate at inclusion, at 6 months and at 12 months [ Time Frame: at inclusion, at 6 months and at 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	51
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Experimental Administration of Milk	Other: Milk sublingual administration of milk
Placebo: Placebo Comparator meals without milk	Other: Milk placebo

Detailed 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

Eligibility

Ages Eligible for Study:	5 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children, male and female
Children > 5 years
Children with IgE-mediated cow milk allergy, with detectable specific IgE (> 0.10 KU/l) and an immediate type reaction during oral provocation test for a cumulated dose < 100 mL of milk).
Children and parents or tutors having given their informed consent after complete information

Exclusion Criteria:

Children participating or having already participated to a drug trial during the 3 preceding months
Children with immune deficiency
Children with disabling disease, preventing from a correct practice of sublingual treatment
Children receiving steroid therapy
Children refusing to participateSevere food neophobia
Reaction to placebo during the double blind oral provocation test
Severe anaphylactic reaction with milk during the 6 preceding months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874627

Contacts

Contact: Christophe Dupont, MD, PhD	00 33 1 40 48 80 60	christophe.dupont@svp.aphp.fr
Contact: Raphaël Serreau, MD, PhD	00 33 1 58 41 11 80	raphael.serreau@cch.aphp.fr

Locations

France
Hospital Cochin - Saint-Vincent de Paul	Recruiting
Paris, France, 75679
Principal Investigator: Christophe Dupont, MD, PhD

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

ESPCI

Investigators

Principal Investigator:

Christophe Dupont, MD, PhD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Responsible Party:	Department Clinical Research of Developpement ( Saliha Djane )
Study ID Numbers:	K070602
Study First Received:	April 1, 2009
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00874627 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

children > 5 years old
IgE-mediated
cow milk allergy
IgE-mediated cow milk allergy persisting after 5 years

Study placed in the following topic categories:

Food Hypersensitivity
Hypersensitivity
Milk Hypersensitivity
Hypersensitivity, Immediate

Additional relevant MeSH terms:

Food Hypersensitivity
Hypersensitivity
Immune System Diseases
Milk Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on September 11, 2009