Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-03-29 @ 11:24 PM
Study NCT ID:
NCT00874627
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2009-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sublingual Milk Immunotherapy in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016269', 'term': 'Milk Hypersensitivity'}], 'ancestors': [{'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008892', 'term': 'Milk'}], 'ancestors': [{'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2009-04-01', 'studyFirstSubmitQcDate': '2009-04-01', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reactive milk dose at inclusion, at 6 months and at 12 months', 'timeFrame': 'at inclusion, at 6 months and at 12 months'}], 'secondaryOutcomes': [{'measure': 'Skin reaction at inclusion at 6 months and at 12 months', 'timeFrame': 'at inclusion at 6 months and at 12 months'}, {'measure': 'Specific IgE rate at inclusion, at 6 months and at 12 months', 'timeFrame': 'at inclusion, at 6 months and at 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['children > 5 years old', 'IgE-mediated', 'cow milk allergy', 'IgE-mediated cow milk allergy persisting after 5 years'], 'conditions': ['Cow Milk Allergy']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "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).\n\nAnalysis 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).\n\nAnalysis 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).\n\nAnalysis 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children, male and female\n* Children \\> 5 years\n* 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).\n* Children and parents or tutors having given their informed consent after complete information\n\nExclusion Criteria:\n\n* Children participating or having already participated to a drug trial during the 3 preceding months\n* Children with immune deficiency\n* Children with disabling disease, preventing from a correct practice of sublingual treatment\n* Children receiving steroid therapy\n* Children refusing to participateSevere food neophobia\n* Reaction to placebo during the double blind oral provocation test\n* Severe anaphylactic reaction with milk during the 6 preceding months'}, 'identificationModule': {'nctId': 'NCT00874627', 'acronym': 'Lactaide', 'briefTitle': 'Sublingual Milk Immunotherapy in Children', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Sublingual Milk Immunotherapy in Children With IgE-mediated Cow Milk Protein Allergy', 'orgStudyIdInfo': {'id': 'K070602'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Administration of Milk', 'interventionNames': ['Other: Milk']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'meals without milk', 'interventionNames': ['Other: Milk']}], 'interventions': [{'name': 'Milk', 'type': 'OTHER', 'otherNames': ['sublingual administration of milk'], 'description': 'sublingual administration of milk', 'armGroupLabels': ['Experimental']}, {'name': 'Milk', 'type': 'OTHER', 'otherNames': ['placebo'], 'description': 'placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75679', 'city': 'Paris', 'country': 'France', 'facility': 'Hospital Cochin - Saint-Vincent de Paul', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Christophe Dupont, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique Hopitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'ESPCI Paris', 'class': 'OTHER'}, {'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}