Sublingual Milk Immunotherapy in Children

NCT00874627 | Completed

• 1 other identifier: K070602
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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).

Conditions

Cow Milk Allergy

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  at inclusion, at 6 months and at 12 months

Secondary Outcomes (2)

• Skin reaction at inclusion at 6 months and at 12 months

  at inclusion at 6 months and at 12 months

• Specific IgE rate at inclusion, at 6 months and at 12 months

  at inclusion, at 6 months and at 12 months

Study Arms (2)

Experimental

EXPERIMENTAL

Administration of Milk

Other: Milk

Placebo

PLACEBO COMPARATOR

meals without milk

Other: Milk

Interventions

Milk OTHER

sublingual administration of milk

Also known as: sublingual administration of milk

Experimental

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• ESPCI Paris: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hospital Cochin - Saint-Vincent de Paul

Paris, 75679, France

Location

MeSH Terms

Conditions

Milk Hypersensitivity

Interventions

Milk

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Christophe Dupont, MD, PhD

  Assistance Publique Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 2, 2009
• Study Start: September 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 16, 2025

Record last verified: 2025-10

Locations

FR (1)