Sublingual Milk Immunotherapy in Children (Lactaide)

This study has been completed.
Sponsor:
Collaborator:
ESPCI
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00874627
First received: April 1, 2009
Last updated: December 10, 2012
Last verified: December 2012
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Sublingual Milk Immunotherapy in Children With IgE-mediated Cow Milk Protein Allergy

Resource links provided by NLM:


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 ]

Enrollment: 51
Study Start Date: September 2008
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
Administration of Milk
Other: Milk
sublingual administration of milk
Other Name: sublingual administration of milk
Placebo Comparator: Placebo
meals without milk
Other: Milk
placebo
Other Name: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Hospital Cochin - Saint-Vincent de Paul
Paris, France, 75679
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: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00874627     History of Changes
Other Study ID Numbers: K070602
Study First Received: April 1, 2009
Last Updated: December 10, 2012
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

Additional relevant MeSH terms:
Hypersensitivity
Milk Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on October 22, 2014