Milk under the tongue: a new hope for kids with dairy allergy?
NCT ID NCT00874627
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether giving small amounts of milk under the tongue (sublingual immunotherapy) could help children with cow milk allergy tolerate more milk. Fifty-one children aged 5 and older with confirmed IgE-mediated cow milk allergy participated. Over 12 months, researchers measured how much milk the children could safely drink before reacting, along with skin reactions and allergy blood tests.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- milk
- What this could lead to
- If it works, this could offer a way to help children with cow milk allergy safely consume more milk without severe reactions.
- What could go wrong
- This is a small, early-phase study with only 51 children, so results may not apply to everyone. There is also a risk of allergic reactions during treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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51 people
The number who actually took part.
- Start date
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Sep 2008
- Finished
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Dec 2012
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 to 17 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hospital Cochin - Saint-Vincent de Paul
Paris, 75679, France
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