Cow Milk AllergyLactaideNCT00874627
Sublingual Milk Immunotherapy in Children
A study testing Milk in people with Cow Milk Allergy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Cow Milk Allergy
- What is being tested?
- Milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2008to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sublingual Milk Immunotherapy in Children With IgE-mediated Cow Milk Protein Allergy
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).
Read the 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
- Conditions
- Cow Milk Allergy
- Being tested
- Milk
- Keywords
- children > 5 years old, IgE-mediated, cow milk allergy, IgE-mediated cow milk allergy persisting after 5 years
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilkOther
Also called sublingual administration of milk
sublingual administration of milk
MilkOther
Also called placebo
placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Administration of Milk Receives: Other: Milk |
| Placebo | Placebo comparator | meals without milk Receives: Other: Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactive milk dose at inclusion, at 6 months and at 12 months
Measured: at inclusion, at 6 months and at 12 months
Secondary outcomes (2)
Skin reaction at inclusion at 6 months and at 12 months
Measured: at inclusion at 6 months and at 12 months
Specific IgE rate at inclusion, at 6 months and at 12 months
Measured: at inclusion, at 6 months and at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startSep 2008
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cow Milk AllergyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- ESPCI Paris, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Christophe Dupont, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874627
- Sponsor's protocol ID
- K070602
- Acronym
- Lactaide
- Status last verified
- Oct 2025
- First submitted
- 1 Apr 2009
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Milk Immunotherapy in Children With IgE-mediated Cow Milk Protein Allergy
- ClinicalTrials.gov ID
- NCT00874627
- Acronym / sponsor ID
- Lactaide / K070602
- Conditions
- Cow Milk Allergy
- Keywords
- children > 5 years old, IgE-mediated, cow milk allergy, IgE-mediated cow milk allergy persisting after 5 years
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- ESPCI Paris, URC-CIC Paris Descartes Necker Cochin
- Study start
- Sep 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: MilkAdministration of Milk |
| Placebo | Placebo comparator | Other: Milkmeals without milk |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MilkAlso: sublingual administration of milksublingual administration of milk | Other | Experimental |
| MilkAlso: placeboplacebo | Other | Placebo |
Primary outcome
Reactive milk dose at inclusion, at 6 months and at 12 months
Time frame: at inclusion, at 6 months and at 12 months
2 secondary outcomes
Skin reaction at inclusion at 6 months and at 12 months
Time frame: at inclusion at 6 months and at 12 months
Specific IgE rate at inclusion, at 6 months and at 12 months
Time frame: at inclusion, at 6 months and at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
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A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Dupont, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk in people with Cow Milk Allergy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reactive milk dose at inclusion, at 6 months and at 12 months (time frame: at inclusion, at 6 months and at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.