A pilot study to examine the effect of adjunctive anti-IgE antibody on improving the efficacy and safety of oral immunotherapy for cow's milk allergy.

A pilot study to examine the effect of adjunctive anti-IgE antibody on improving the efficacy and safety of oral immunotherapy for cow's milk allergy. - A pilot study of adjunctive anti-IgE antibody on oral immunotherapy for cow's milk allergy.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018794

Enrollment

Registered

2015-08-25

Start date

2015-08-25

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Cow&#39

Interventions

Oral immunotherapy in combination with ant-IgE therapy.Patients are administered with omalizumab at four-weekly intervals for 20 weeks from enrollment. The appropriate dose of omalizumab is determined

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Severe cow's milk allergic patients between 6-20 years diagnosed by oral challenge test within 3 months. Threshold must be less than 3ml. 2)Patients, whose dose of Xolair (omalizumab) according to administration criteria of asthma is less than 150mg/month.

Exclusion criteria

Exclusion criteria: 1)Patients with past history of tracheal tubing or ICU admission due to anaphylaxis to foods. 2)Patients with severe systemic disease (Heart diseases, Inflammatory diseases, uncontrolled baronchial asthma). 3)Patients using beta blocker. 4)Patients with past history of hypersensitivity to omalizumab. 5)Patients who do not agree to participate in this study. 6)Patients whom physician regards inadequate.

Design outcomes

Primary

Measure	Time frame
To perform oral immunotherapy (OIT) for cow's milk allergy diagnosed by oral challenge test in combination with anti-IgE therapy and to compare frequency and severity of adverse events until reaching the target amount with conventional OIT.	—

Countries

Japan

Contacts

Public ContactIkuya Tsuge

Fujita Health university Faculty of medicine, Department of pediatrics.

itsuge@fujita-hu.ac.jp+81-562-93-9251

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

A pilot study to examine the effect of adjunctive anti-IgE antibody on improving the efficacy and safety of oral immunotherapy for cow&#39;s milk allergy.