Oral Immunotherapy for Hen's Egg, Cow's Milk, and Wheat allergic children at outpatient clinic.

Oral Immunotherapy for Hen's Egg, Cow's Milk, and Wheat allergic children at outpatient clinic. - Outpatient Oral Immunotherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013769

Enrollment

100

Registered

2014-04-21

Start date

2014-04-21

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

The target amount of ingestion, regarding tolerance acquisition, is defined one heated hen&#39

s egg, 100ml of cow&#39

s milk, and 100g of Japanese Udon noodles. The maximum amount of ingestion at home is 100% amount of that in group A and 25% of that in group B, during one year oral immunotherapy.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects, aged 3-15 years old, undergo oral food challenge within the 3 months before this trial. They are confirmed mild or moderate positive objective symptoms caused by hen's egg, cow's milk, or wheat ingestion challenge. The threshold for eliciting positive symptoms is more than a thirty-second hen's egg and not greater than a quarter of that for egg allergic children. Also that for cow's milk is more than 3ml and not greater than 25ml, and that for wheat is more than 3g of Udon noodles and not greater than 25g of that.

Exclusion criteria

Exclusion criteria: The threshold for eliciting positive symptoms is less than or equal to a thirty-second hen's egg, 3ml of cow's milk, or 3g of Udon noodles by oral food challenge test. The subject who is treated by adrenaline injection at oral food challenge test just before this study. The subject who has not-well treated atopic dermatitis, bronchial asthma, or any underlying disease. The subject who is not appropriate for oral immunotherapy, judged by medical doctor.

Design outcomes

Primary

Measure	Time frame
The purpose of this study is to clarify dose dependent outcome, regarding tolerance acquisition and incidence rate of symptoms by outpatient oral immunotherapy. Patients are enrolled in two groups, which are divided by target amounts of OIT ingestion as 100% or 25% of maximum ingestion amount.	—

Secondary

Measure	Time frame
To investigate the efficacy of oral immunotherapy, compared to natural course without the therapy. To confirm the safety of outpatient oral immunotherapy for mild and moderate food allergic children. To analyze the reactivity for oral immunotherapy, stratified by their severity of food allergy. Regarding the OIT patients who haven't reached tolerance at 1 year follow up, they can continue OIT for longer period with their informed consent with its will for participation in advance. The outcome at 2 years' follow up is analyzed in addition to that at 1 year.	—

Measure

Time frame

To investigate the efficacy of oral immunotherapy, compared to natural course without the therapy. To confirm the safety of outpatient oral immunotherapy for mild and moderate food allergic children. To analyze the reactivity for oral immunotherapy, stratified by their severity of food allergy. Regarding the OIT patients who haven't reached tolerance at 1 year follow up, they can continue OIT for longer period with their informed consent with its will for participation in advance. The outcome at 2 years' follow up is analyzed in addition to that at 1 year.

—

Countries

Japan

Contacts

Public ContactKiyotake Ogura

National Hospital Organization Sagamihara National Hospital Department of Allergy, Clinical Research Center for Allergy and Rheumatology

foodallergy@sagamihara-hosp.gr.jp042-742-7311

Outcome results

None listed

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

Oral Immunotherapy for Hen&#39;s Egg, Cow&#39;s Milk, and Wheat allergic children at outpatient clinic.