Oral Immunotherapy for Children With Cow's Milk Allergy

Condition(s) studied

Investigational drug(s) / intervention(s)

Oral immunotherapy with cow's milk: Oral immunotherapy with cow's milk for 1-1.5 years

Study summary

This clinical trial aims to investigate if oral immunotherapy can help children with cow's milk allergy tolerate cow's milk.

Children aged 6-18 months can take part in the trial.

Main question: What percentage of children can tolerate cow's milk after oral immunotherapy, compared with children who avoid cow's milk?

Children are assigned to these two groups by chance.

Children receiving oral immunotherapy will:

* Take a small, increasing amount of cow's milk daily for 1-1.5 years
* Attend clinic or online visits each time the dose is increased
* Record missed doses

All children will:

* Provide blood samples to measure allergy-related markers
* Undergo an oral food challenge with cow's milk after 1-1.5 years to assess how much they can tolerate
* Report allergic reactions (parent-reported)
* Complete questionnaires (parent-reported)
* Participate in an end-of-study telephone interview with an allergy nurse (parent-reported)

Eligibility

Primary outcome measure(s)

• Tolerance to cow's milk (4000 mg) — 1-1.5 years after enrollment
  Proportion of children who tolerate a cumulative dose of 4343 mg of cow's milk protein at an oral food challenge

Trial sites (5)

Other trials for the same condition