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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024729

Enrollment

Registered

2016-11-14

Start date

2016-11-15

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 more than 3ml, and 25 ml or less.

Exclusion criteria

Exclusion criteria: 1) patients who are on other immunotherapy 2)patients who have heart, liver and kidney diseases 3)patients with ncontrolled asthma or atopic dermatitis

Design outcomes

Primary

Measure	Time frame
Proportion of the subjects who tolerate more than 25 ml of milk (cumulative dose) at oral milk challenge after the treatment for 1 year	—

Secondary

Measure	Time frame
1.Safety: local reaction, systemic immediate-type allergic reaction and other 2.Days:reaching the maintenance dose 3.Prick test 4.Specific IgE and IgG4	—

Countries

Japan

Contacts

Public ContactYu Kuwabara

National Hospital Organization Mie National Hospital Allergy Center

yu_surrealist@hotmail.co.jp+81592322531

Outcome results

None listed

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