Tolerance induction in cow's milk allergy

Tolerance induction in cow's milk allergy - Tolerance induction in cow's milk allergy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30721

Enrollment

Registered

2008-04-08

Start date

2007-07-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cow's milk allergy/ Cow's milk protein allergy

Interventions

Oligosaccharides and glycoproteins mixed with hydrolysed formula or breastmilk.

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Child Cow's milk allergy diagnosed by double blind, placebocontrolled randomised foodchallenge

Exclusion criteria

Exclusion criteria: immune-mediated disease

Design outcomes

Primary

Measure	Time frame
The percentage of infants who develop tolerance at each outpatient day clinic visit (OPD), determined by a DBPCFC.	—

Secondary

Measure	Time frame
The incidence and severity of asthma and allergic rhinitis. Serum Total IgE, IgG and IgG4 concentration. Newly acquired sensitizations, measured by specific IgE for the most prevalent food-and inhalant allergens. Peripheral blood derived T-cell phenotype, antigen-specific proliferation and cytokine production and/or expression of intracellular transcription factors specific for regulatory T-cells and cytokine production. Stool samples will be studied for identification and quantification of micro-organisms.	—

Measure

Time frame

The incidence and severity of asthma and allergic rhinitis. Serum Total IgE, IgG and IgG4 concentration. Newly acquired sensitizations, measured by specific IgE for the most prevalent food-and inhalant allergens. Peripheral blood derived T-cell phenotype, antigen-specific proliferation and cytokine production and/or expression of intracellular transcription factors specific for regulatory T-cells and cytokine production. Stool samples will be studied for identification and quantification of micro-organisms.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)