efficacy and safety of allergen extract dropping therapy for severe peanut and nut (walnut) allergy

efficacy and safety of Ultra low dose oral immunotherapy for severe nut allergy; open label multi centered observational study - ULDOIT for severe peanut and nut(walnut) allergy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000048007

Enrollment

Registered

2022-06-15

Start date

2019-03-01

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: the subjects whose severe adverse reactions to peanut or nut(walnut)- intake have been diagnosed by physicians, and whose prick tests or antigen and its component specific IgE levels have shown positive results. The above subjects are also required to fulfill the conditions mentioned below. 1.who have been on strict elimination diet and incapable of starting oral immunotherapy because of severe adverse reactions to oral food challenge tests or accidental ingestions in the past. 2.who have not been able to increase the intake-dose because of adverse reactions during oral immunotherapy

Exclusion criteria

Exclusion criteria: the subjects who have the conditions bellow 1.poorly controlled atopic dermatitis 2.poorly controlled asthma 3.immunodeficiency 4.taking beta blockers 5. pregnancy 6. taking medications for psychiatric disorders except child developmental disorders 7.malignant diseases

Design outcomes

Primary

Measure	Time frame
the rate of the subjects who could have been administered a usual oral immunotherapy using peanut or nut(walnut) powder in mg unit during the test period.	—

Secondary

Measure	Time frame
1.oral challenge threshold changes of serially diluted allergen extracts; verified every month till 24 months after the research start. 2. oral challenge threshold changes of antigen powders in mg units.(every month) 3.threshold changes of skin prick tests of serially diluted allergen extracts.(every year) 4. changes of wheel size of skin prick tests of diluted allergen extracts.( every year) 5. antigen specific IgE level change (every year) 6.Basophil Activation Test results on several diluted allergen extracts(before and after the study) 7.the rate of subjects who could intake allergen nut containing foods. 8.safety evaluation (the rate of adverse reactions at challenge phases in a clinic setting and maintenance phases at home)	—

Measure

Time frame

1.oral challenge threshold changes of serially diluted allergen extracts; verified every month till 24 months after the research start. 2. oral challenge threshold changes of antigen powders in mg units.(every month) 3.threshold changes of skin prick tests of serially diluted allergen extracts.(every year) 4. changes of wheel size of skin prick tests of diluted allergen extracts.( every year) 5. antigen specific IgE level change (every year) 6.Basophil Activation Test results on several diluted allergen extracts(before and after the study) 7.the rate of subjects who could intake allergen nut containing foods. 8.safety evaluation (the rate of adverse reactions at challenge phases in a clinic setting and maintenance phases at home)

—

Countries

Japan

Contacts

Public Contactkyoko Nishikage

Yokohama Nishikage Clinic: kids and allergies medical department

kyoko@yokohama-nishikage.clinic0453235115

Outcome results