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Sublingual Milk Immunotherapy in Children (Lactaide)

Primary Purpose

Cow Milk Allergy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Milk
Milk
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cow Milk Allergy focused on measuring children > 5 years old, IgE-mediated, cow milk allergy, IgE-mediated cow milk allergy persisting after 5 years

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Cochin - Saint-Vincent de Paul

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Placebo

Arm Description

Administration of Milk

meals without milk

Outcomes

Primary Outcome Measures

Reactive milk dose at inclusion, at 6 months and at 12 months

Secondary Outcome Measures

Skin reaction at inclusion at 6 months and at 12 months
Specific IgE rate at inclusion, at 6 months and at 12 months

Full Information

First Posted
April 1, 2009
Last Updated
December 10, 2012
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
ESPCI Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00874627
Brief Title
Sublingual Milk Immunotherapy in Children
Acronym
Lactaide
Official Title
Sublingual Milk Immunotherapy in Children With IgE-mediated Cow Milk Protein Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
ESPCI Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow Milk Allergy
Keywords
children > 5 years old, IgE-mediated, cow milk allergy, IgE-mediated cow milk allergy persisting after 5 years

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Administration of Milk
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
meals without milk
Intervention Type
Other
Intervention Name(s)
Milk
Other Intervention Name(s)
sublingual administration of milk
Intervention Description
sublingual administration of milk
Intervention Type
Other
Intervention Name(s)
Milk
Other Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Reactive milk dose at inclusion, at 6 months and at 12 months
Time Frame
at inclusion, at 6 months and at 12 months
Secondary Outcome Measure Information:
Title
Skin reaction at inclusion at 6 months and at 12 months
Time Frame
at inclusion at 6 months and at 12 months
Title
Specific IgE rate at inclusion, at 6 months and at 12 months
Time Frame
at inclusion, at 6 months and at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Dupont, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Cochin - Saint-Vincent de Paul
City
Paris
ZIP/Postal Code
75679
Country
France

12. IPD Sharing Statement

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Sublingual Milk Immunotherapy in Children

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