Study of diet for tolerance induction with food allergy children. Randomized controlled trial to evaluate efficacy of low dose ingestion of responsible food for children with food allergy.

Study of diet for tolerance induction with food allergy children. Randomized controlled trial to evaluate efficacy of low dose ingestion of responsible food for children with food allergy. - Study of diet for tolerance induction with food allergy children. Randomized controlled trial to evaluate efficacy of low dose ingestion of responsible food for children with food allergy.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019671

Enrollment

Registered

2015-11-06

Start date

2014-10-16

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 (Hen&#39

Interventions

Low dose ingestion of responsible food( a thirty-second of hen&#39

s egg for egg allergy,3ml of cow&#39

s milk for milk allergy,or 3g of Udon noodles for wheat allergy) on alternate days for 6 months. Complete elimination therapy for 6 months.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with immediate allergic reactions to hen's egg,cow's milk or wheat. 2)Patients are confirmed obvious positive objective symptoms caused by oral food challenge test(hen's egg,cow's milk,or wheat) or ingestion of those by mistake and the titer of specific IgE is more than 95% positive predictive value at the probability curve. 3)The threshold for eliciting positive symptoms is more than a thirty-second hen's egg and not greater than a eighth of that for egg allergic children. Also that for cow's milk is more than 3ml and not greater than 24ml,and that for wheat is more than 3g of Udon noodles and not greater than 24g of that.

Exclusion criteria

Exclusion criteria: 1)The patients who cannot be obtained informed consent by themselves or their guardians. 2)The threshold for eliciting positive symptoms is less than or equal to a thirty-second hen's egg,3ml of cow's milk, or 3g of Udon noodles by oral food challenge test. 3)Patiens with a history of anaphylactic shock caused by oral food challenge test(hen's egg,cow's milk,or wheat) or ingestion of those by mistake. 4)The patiens with poorly controlled asthma or atopic dermatitis. 5)The patient who the attending physician determines inappropriate.

Design outcomes

Primary

Measure	Time frame
Difference of threshold of tolerance dose after treatment between low dose ingestion of responsible food on alternate days and complete elimination for food allergy.	—

Secondary

Measure	Time frame
1)Desensitization of food allergy 2)The change of antigen-specific antibody IgE and IgG4 in serum,and result of skin prick test. 3)The change of quarity of life by questionnaire. 4)Incidence of bronchial asthma.	—

Countries

Japan

Contacts

Public ContactMayu Shimizu

Showa university school of medicine Department of pediatrics

mayu-shimi@med.showa-u.ac.jp03-3784-8000

Outcome results

None listed

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