UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Supplemental effect of fermented soy product on rush oral immunotherapy (F-SOI)- Double blind - randomized placebo control trial -
Title of the study (Brief title)	F-SOI
Region	Japan

Condition
Condition	food allergy
Classification by specialty	Clinical immunology Pediatrics Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of combined therapy comprising fermanted soy product with rush oral immunotherapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The total score of allergic reaction score plus rescue drug score during rash phase of OIT.
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	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
Interventions/Control_2	the consumption of plasebo from 1~2 month before starting ROIT until 3 month after the end of rash phase of OIT
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	5 years-old <
Age-upper limit	18 years-old >=
Gender	Male and Female
Key inclusion criteria	patient with severe food allergy for egg, milk, wheat diagnosed by oral food challenge
Key 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
Target sample size	55

Research contact person
Name of lead principal investigator	Komei Ito
Organization	Aichi Children's Health and Medical Center
Division name	Department of Allergy
Address	7-426, Morioka, Obu, Aichi 474-8710, Japan
TEL	0562-43-0500
Email	koumei_itoh@mx.achmc.pref.aichi.jp

Public contact
Name of contact person	Iwao Tajima
Organization	Aichi Children's Health and Medical Center
Division name	Department of Allergy
Address	7-426, Morioka, Obu, Aichi 474-8710, Japan
TEL	0562-43-0500
Homepage URL
Email	iwao_tajima@sk00106.achmc.pref.aichi.jp

Sponsor
Institute	Aichi Children's Health and Medical Center
Institute
Department

Funding Source
Organization	NICHIMO BIOTICS Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	あいち小児保健医療総合センター(愛知県）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 11 Day
Anticipated trial start date	2016 Year 05 Month 21 Day
Last follow-up date	2018 Year 06 Month 30 Day
Date of closure to data entry	2018 Year 06 Month 30 Day
Date trial data considered complete	2018 Year 08 Month 31 Day
Date analysis concluded	2018 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 21 Day
Last modified on	2018 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026259