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Comparison of effectiveness of daily intake and twice weekly intake in low dose oral immunotherapy for food allergy - investigator-blinded, randomized, parallel group controlled trial -

Comparison of effectiveness of daily intake and twice weekly intake in low dose oral immunotherapy for food allergy - investigator-blinded, randomized, parallel group controlled trial - - EFAIT study: Exposure Frequency of Allergen in oral ImmunoTherapy

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026266
Enrollment
40
Registered
2017-03-04
Start date
2016-03-04
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

the participants in frequent group intake the allergic food daily in low dose oral immunotherapy the participants in intermittent group intake the allergic food twice weekly in low dose oral immunothe

Sponsors

Hamamatsu University School of Medicine
Lead Sponsor
Morimachi Hospital Chutoen General Medical Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children aged 6 months or older, 6 years or younger Children who were diagnosed with a positive by open oral food challenge (OFC) with boiled egg white / milk, which total dose of 1-10 g. Excluding positive only for the symptoms around the oral cavity. There are blood test results within 3 months of OFC which performed prior to study registration. Children who can be Track one year and track confirmation OFC one year later. A person who consented to the study by a substitute person who is a parental author in writing.

Exclusion criteria

Exclusion criteria: Children already doing oral immunotherapy for the relevant foods, including irregular processed goods. Children who intake the other allergic food for oral immunotherapy within 2 hours of food intake for this trial. Those with poor control of atopic dermatitis and bronchial asthma. Children with chronic urticaria. Children who is planning to move within 1 year. The cases who have serious complications and doctor determines that it is inappropriate for this study

Design outcomes

Primary

MeasureTime frame
Difference of amount of intake in oral food challenge after 12 +- 2 months from start of low dose oral immunotherapy between frequent (daily intake) group and intermittent (twice weekly intake) group.

Secondary

MeasureTime frame
Primary outcome which divided into subgroup of egg allergy and milk allergy. Difference of Egg white and ovomucoid-sIgE or milk and casein-sIgE after 12 +- 2 months from start the OIT between the frequent and the intermittent groups, which divided into the egg and the milk subgroups. Difference of Egg white and ovomucoid-sIgE or milk and cazein-sIgG4 after 12 +- 2 months from start the OIT between the frequent and the intermittent groups, which divided into the egg and the milk subgroups. Difference of increasing rate of amount of intake in oral food challenge from before the OIT to after the OIT between the frequent group and the intermittent group. Difference of increasing rate of ovomucoid-sIgE in egg allergy and milk-sIgE in milk allergy from before the OIT to after the OIT between the frequent group and the intermittent group. Difference of the FAQ after 12 +- 2 months from start of the OIT between the frequent group and the intermittent group. Difference of the VAS scale for degree of difficulty of intake the foods after 12 +- 2 months from start of the OIT between the frequent group and the intermittent group.

Countries

Japan

Contacts

Public ContactOsamu Natsume

Hamamatsu University School of Medicine Pediatrics

natsumeo@hama-med.ac.jp053-435-2312

Outcome results

None listed

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