CompletedNot Applicable

Sublingual Milk Immunotherapy in Children

France51 participantsStarted 2008-09

Plain-language 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).

Who can participate

Age range

5 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: at inclusion, at 6 months and at 12 months

Trial details

NCT IDNCT00874627

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-09

View on ClinicalTrials.gov More Cow Milk Allergy trials

Who can participate

Age range

5 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.