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Fixed low-dose antigen intake for tree nut allergies; an open-label, randomized trial

Fixed low-dose antigen intake for tree nut allergies; an open-label, randomized trial - Fixed low-dose antigen intake for tree nut allergies

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000057335
Enrollment
60
Registered
2025-03-19
Start date
2024-03-01
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

Fixed low-dose antigen intake. Ingest antigen every day according to the protocol. Elimination diet

Sponsors

Aichi Children's Health and Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children with severe food allergies, such as tree nut or peanut allergies, who are capable of possessing and managing an epinephrine auto-injector.

Exclusion criteria

Exclusion criteria: Patients with severe comorbidity Patients with uncontrollable asthma or atopic dermatitis Patients whose parents can not manage adrenalin autoinjector Patients who required epinephrine (excluding inhalation) during the entry oral food challenge or who ended with only mild subjective symptoms. Patients deemed unsuitable by the physician

Design outcomes

Primary

MeasureTime frame
Proportion of patients with a negative oral food challenge results six months after starting intake (or elimination)

Secondary

MeasureTime frame
Safety and continuity of antigen intake The threshold dose of antigen and severity of allergic reaction provoked in OFCs. The shift of laboratory data (e.g. specific IgE titer)

Countries

Japan

Contacts

Public ContactKatsumasa Kitamura

Aichi Children's Health and Medical Center Allergy and Immunology Center, Department of Allergy

katsumasa_kitamura@sk00106.achmc.pref.aichi.jp0562-43-0500

Outcome results

None listed

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