Tolerance induction through non-avoidance to prevent persistent food allergy

Tolerance induction through non-avoidance to prevent persistent food allergy - TINA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00016764

Enrollment

120

Registered

2020-01-15

Start date

2020-03-02

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

T78.1

Interventions

Group 1: Children and adults with challenge proven peanut and/or tree nut allergy. Group I-A (Intervention group: ‘strict peanut and/or tree nut avoidance) will get instruction from our dieticians on

Eligibility

Sex/Gender

All

Age

12 Months to 67 Years

Inclusion criteria

Inclusion criteria: -adults and children, age 1-67 years -suspected or known peanut and/or tree nut allergy -signed informed consent of patient/parents

Exclusion criteria

Exclusion criteria: - Other severe diseases (cardiac, cystic fibrosis, congenital) - participation in another interventional trial that requires consumption of food protein - uncontrolled asthma - usage of antihistamines 3-5 days before oral food challenge - therapy with beta-blocker and/or ACE-inhibitors - systemic immunosuppression - pregnancy or lactation - allergic reaction to less than the 5th dose of peanut and/or tree nut protein during oral food challenge

Design outcomes

Primary

Measure	Time frame
Clinical tolerance to peanut or tree nuts after one year assessed by oral food challenge (up to the repetitive cumulative dose).	—

Secondary

Measure	Time frame
-Clinical tolerance to peanut after one year assessed by oral food challenge -Clinical tolerance to tree nuts in general and to individual tree nuts after one year assessed by oral food challenge. -Change in threshold level upon oral peanut or tree nut challenge after one year. -Change in peanut- and/or tree nut- specific wheal size as well as IgE and IgG4 at 12 months from baseline. -Incidence, frequency, severity and relatedness of (serious) adverse events, especially immediate type allergic reactions and gastrointestinal problems, including accidental allergic reactions during the study assessed by diaries, telephone interviews and during clinical visits. -Change of SCORAD, EASIscore and topical eczema treatment in participants with atopic dermatitis at 4, 8 and 12 months from baseline. -Change in generic and disease specific quality of life during and after the study from baseline assessed by questionnaires	—

Measure

Time frame

-Clinical tolerance to peanut after one year assessed by oral food challenge -Clinical tolerance to tree nuts in general and to individual tree nuts after one year assessed by oral food challenge. -Change in threshold level upon oral peanut or tree nut challenge after one year. -Change in peanut- and/or tree nut- specific wheal size as well as IgE and IgG4 at 12 months from baseline. -Incidence, frequency, severity and relatedness of (serious) adverse events, especially immediate type allergic reactions and gastrointestinal problems, including accidental allergic reactions during the study assessed by diaries, telephone interviews and during clinical visits. -Change of SCORAD, EASIscore and topical eczema treatment in participants with atopic dermatitis at 4, 8 and 12 months from baseline. -Change in generic and disease specific quality of life during and after the study from baseline assessed by questionnaires

—

Countries

Germany

Contacts

Public ContactFriederike Bluhme

Charité-Universitätsmedizin Berlin; Klinik für Pädiatrie m.S. Pneumologie und Immunologie mit Intensivmedizin

tina-studie@charite.de030450516466

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026