UMIN-CTR Clinical Trial

Basic information
Public title	Slow Low-dose Oral Immunotherapy [SLOIT] for children with food allergies - non-randomized control trial -
Acronym	SLOIT for food allergies
Scientific Title	Slow Low-dose Oral Immunotherapy [SLOIT] for children with food allergies - non-randomized control trial -
Scientific Title:Acronym	SLOIT for food allergies
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy of Slow Low-dose Oral Immunotherapy (SLOIT)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the proportion of patients with negative results of oral food challenge for boiled egg white, cow's milk, udon noodle (0.2 - 0.5 - 1 - 2 - 5g or mL 30min interval)
Key secondary outcomes	Safety and continuity of the therapy. The threshold dose of antigen and severity of allergic reaction provoked in OFCs. The shift of laboratory data (e.g. specific IgE titer) The frequency of rescue drug use and emergency department visit due to expected and unexpected allergic reaction in both groups.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Slow Low-dose Oral Immunotherapy Ingesting allergen(boiled egg white, whole milk, udon noodle) every day according to the protocol.
Interventions/Control_2	elimination diet
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	2 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 during oral immunotherapy for other food antigen patients with severe comorbidity patients with uncontrollable asthma or atopic dermatitis patients whose parents can not manage adrenalin autoinjector patients who have developed anaphylaxis by tiny antigen (less than 1mL of milk or 1g of boiled egg, udon noodle) within one year before the oral food challenge. patients whom the doctor asses ineligible
Target sample size	300

Research contact person
Name of lead principal investigator	1st name komei Middle name Last name Ito
Organization	Aichi Children's Health and Medical Center
Division name	Department of Allergy
Zip code	474-8710
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	1st name Shiro Middle name Last name Sugiura
Organization	Aichi Children's Health and Medical Center
Division name	Department of Allergy
Zip code	474-8710
Address	7-426, Morioka, Obu, Aichi 474-8710, Japan
TEL	0562-43-0500
Homepage URL
Email	bee_jayz@hotmail.com

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

Funding Source
Organization	Nothing
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Aichi Childrens Health and Medical Center
Address	7-426, morioka, obu, Aichi
Tel	0562-43-0500
Email	bee_jayz@hotmail.com

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

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 04 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 25 Day
Date of IRB	2015 Year 03 Month 26 Day
Anticipated trial start date	2015 Year 03 Month 04 Day
Last follow-up date	2018 Year 06 Month 30 Day
Date of closure to data entry	2018 Year 07 Month 30 Day
Date trial data considered complete	2018 Year 12 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 05 Month 04 Day
Last modified on	2020 Year 05 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019847