A randomized placebo-controlled study to explore novel immunotherapy for food allergy: Effect of adjunctive TGF-rich food in a rush oral immunotherapy for milk allergy

A randomized placebo-controlled study to explore novel immunotherapy for food allergy: Effect of adjunctive TGF-rich food in a rush oral immunotherapy for milk allergy - Effect of adjunctive TGF-rich food in rush oral immunotherapy for milk allergy

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016114

Enrollment

Registered

2015-01-06

Start date

2015-01-06

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 (milk)

Interventions

Milk-derived TGF-beta-enriched food Oral immunotherapy with milk

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Milk allergy patients definitively diagnosed by oral food challenge with threshold of above 1ml, and 10 ml or less.

Exclusion criteria

Exclusion criteria: 1) Allergy to soy bean or dextrin, which are contained in placebo 2) Poorly controlled bronchial asthma and/or atopic dermatitis (If controlled with optimal pharmaceutical therapy, not excluded)

Design outcomes

Primary

Measure	Time frame
Change in threshold of oral food challenge test	—

Secondary

Measure	Time frame
Number of adrenaline use for severe induced symptoms	—

Countries

Japan

Contacts

Public ContactMizuho Nagao

Mie National Hospital Institute for Clinical Research

nagaomizuho@mie-m.hosp.go.jp+81592322531

Outcome results

None listed

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