Study on the gradual introduction of baked milk foods for the treatment of cow’s milk allergy.

Stepwise Introduction Protocol of Extensively Heat-Processed Milk in the Treatment of IgE-Mediated Cow’s Milk Allergy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-3x9ypky

Enrollment

Registered

2026-04-13

Start date

2019-02-10

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Cow&apos

Interventions

This is an open-label randomized controlled clinical trial. In the intervention group, there will be a gradual and systematic intake of extensively heat-processed milk as a treatment for allergic indi

Eligibility

Age

2 Years to No maximum

Inclusion criteria

Inclusion criteria: A convincing clinical history of IgE-mediated cow’s milk allergy; positive cow’s-milk–specific IgE (>0.1 kU/L) in the most recent test (collected up to 12 months prior to the date of inclusion) and/or a positive skin prick test (>3mm); casein-specific IgE =50 kU/L in the most recent test, collected within up to 12 months prior to the date of inclusion; evidence of ongoing clinical allergy. The criteria used to define ongoing allergy was the last allergic reaction reported by the patient during the clinical history as follow: less than 1 year for patients aged =4 years and less than 2 years for patients aged =5 years; any gender was included; minimal age 2 years old

Exclusion criteria

Exclusion criteria: Uncontrolled allergic comorbidities such as moderate to severe atopic dermatitis, asthma, and rhinitis; negative cow’s-milk–specific IgE or immediate-reading skin prick test (=0.1 kU/L or =3 mm, respectively), regardless of a clinical history suggestive of allergy; a clinical history of allergic reactions to baked milk within the past 6 months; serum casein levels =51 kU/L; regular consumption of baked milk prior to initiation of the protocol; a confirmed diagnosis of eosinophilic esophagitis; pregnancy; mental or cognitive impairment that precludes understanding of the procedure and assessment of risks, as well as difficulty in promptly recognizing allergic reactions and implementing emergency measures.

Design outcomes

Primary

Measure	Time frame
The goal is for individuals to become able to ingest 150 mL of fresh milk without any allergic reaction.	—

Secondary

Measure	Time frame
A partial increase in tolerance to cow’s milk (i.e., less than 150 mL) is expected as a secondary outcome. Besides that we expect no changes in body mass index at the end of treatment. Regarding biomarkers, a reduction in specific IgE levels, an increase in specific IgG4 levels, an increase in regulatory T lymphocytes (Tregs), a reduction in wheal size on the milk skin prick test, and an improvement in quality of life are expected.**	—

Measure

Time frame

A partial increase in tolerance to cow’s milk (i.e., less than 150 mL) is expected as a secondary outcome. Besides that we expect no changes in body mass index at the end of treatment. Regarding biomarkers, a reduction in specific IgE levels, an increase in specific IgG4 levels, an increase in regulatory T lymphocytes (Tregs), a reduction in wheal size on the milk skin prick test, and an improvement in quality of life are expected.**

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Countries

Contacts

Public ContactPatricia Cunha

Hospital das Clínicas da Universidade de São Paulo

patricia.cunha@hc.fm.usp.br+55(11)982333394

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: May 1, 2026