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Efficacy and safety of omalizumab (anti-IgE monoclinal antibody) on oral immunotherapy for patients with cow's milk allergy (randomized control study)

Efficacy and safety of omalizumab (anti-IgE monoclinal antibody) on oral immunotherapy for patients with cow's milk allergy (randomized control study) - Omalizumab on oral immunotherapy for patients with cow's milk allergy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015545
Enrollment
50
Registered
2014-11-01
Start date
2014-11-01
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

food allergy

Interventions

omalizmab cow&#39
s milk

Sponsors

The Mami Mizutani foundation Kansai Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) The patients that have anaphylaxy with less 10ml of cow's milk product for 2 years or have symptoms of more than grade 2 according to Sampson's score 2) The patients that show more than 17.5 UA/mL of specific cow's milk IgE level. 3) Positive double blind challenge by cow's milk 4) The patients that written informed consent is obtained 5) The patients that show more than 3 mm of wheel (diameter) by skin prick test.

Exclusion criteria

Exclusion criteria: 1) severe bronchial asthma 2) severe atopic dermatitis 3) acute severe illenes 4) Decision of ineligibility by a physician.

Design outcomes

Primary

MeasureTime frame
Evaluation of the symptom provocation threshold change at the time of entry and 8 months after the start of administration of Omalizumab.—

Countries

Japan

Contacts

Public ContactShoichiro Taniuchi

Kansai Medical University Department of Pediatrics

taniuchi@hirakata.kmu.ac.jp072-804-0101

Outcome results

None listed

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