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Supplemental effect of fermented soy product on rush oral immunotherapy (F-SOI)- Double blind - randomized placebo control trial -

Supplemental effect of fermented soy product on rush oral immunotherapy (F-SOI)- Double blind - randomized placebo control trial - - F-SOI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000022826
Enrollment
55
Registered
2016-06-21
Start date
2016-05-21
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 consumption of 600mg/day fermanted soy product from 1~2 month before ROIT to 3 months after the end of rash phase of OIT the consumption of plasebo from 1~2 month before starting ROIT until 3 mont

Sponsors

Aichi Children's Health and Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: patient with severe food allergy for egg, milk, wheat diagnosed by oral food challenge

Exclusion criteria

Exclusion criteria: patients with severe comorbidity patients with uncontrollable asthma or atopic dermatitis patients with severe food allergy for soybeans patients whom the doctor assess ineligible

Design outcomes

Primary

MeasureTime frame
The total score of allergic reaction score plus rescue drug score during rash phase of OIT.

Secondary

MeasureTime frame
The amount of food consumption and the proportion of patients who reached the target dose (20g of boiled egg, 100ml of milk and 100g of udon noodle) at discharge and at 3 months after discharge. The changes in value of laboratory data (e.g. specific IgE titer) The changes in value of the threshold dose of antigen and severity of allergic reaction provoked in OFCs

Countries

Japan

Contacts

Public ContactIwao Tajima

Aichi Children's Health and Medical Center Department of Allergy

iwao_tajima@sk00106.achmc.pref.aichi.jp0562-43-0500

Outcome results

None listed

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