UMIN-CTR Clinical Trial

Basic information
Public title	Safety and Efficacy of slow low-dose oral immunotherapy Shimane version for patients with positive low-dose oral food challenge
Acronym	Shimane-SLOIT 2022
Scientific Title	Safety and Efficacy of slow low-dose oral immunotherapy Shimane version for patients with positive low-dose oral food challenge
Scientific Title:Acronym	Shimane-SLOIT 2022
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy of Shimane-SLOIT
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The result of oral food challenges after one-year of Shimane-SLOIT
Key secondary outcomes	safety of Shimane-SLOIT

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 hen's egg, cow milk and wheat protein everyday with increasing the dose at home whenever they could for every 30 consecutive intakes without obviouslious allergic symptoms)
Interventions/Control_2	complete avoidance of antigen
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	Not applicable
Age-upper limit	16 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Diagnosed with FA of either egg, milk, or wheat. 2) Less than 16 years of age at the time of consent. 3) Weighs 15 kg or more and is able to possess epinephrine autoinjector. 4) Positive oral food challenge with less than 3.5 g of boiled egg white or udon noodles or less than 3.5 mL of cow's milk. 5) Written consent to participate in the study has been obtained from the parents.
Key exclusion criteria	1) severe anaphylaxis induced by oral food challenge 2) uncontrolled bronchial asthma or atopic dermatitis 3) Has malignancy, autoimmune disease, immunodeficiency, severe cardiac disease, or chronic infectious disease 4) Consecutive use of systemic corticosteroids or anticancer agents 5) Undergoing other immunotherapy
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Seiya Middle name Last name Masukane
Organization	Shimane University School of Medicine
Division name	Department of Pediatrics
Zip code	693-8501
Address	89-1, Enyacho, Izumoshi, Shimane
TEL	0853-20-2220
Email	masukane@med.shimane-u.ac.jp

Public contact
Name of contact person	1st name Seiya Middle name Last name Masukane
Organization	Shimane University School of Medicine
Division name	Department of Pediatrics
Zip code	693-8501
Address	89-1, Enyacho, Izumoshi, Shimane
TEL	0853-20-2220
Homepage URL
Email	masukane@med.shimane-u.ac.jp

Sponsor
Institute	Department of Pediatrics, Shimane University School of Medicine
Institute
Department

Funding Source
Organization	Department of Pediatrics, Shimane University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Shimane University School of Medicine Clinical Research Center Clinical Research Support Division
Address	89-1, Enyacho, Izumoshi, Shimane
Tel	0853-20-2259
Email	kenkyu@med.shimane-u.ac.jp

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	2022 Year 10 Month 28 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	Open public recruiting
Date of protocol fixation	2022 Year 09 Month 12 Day
Date of IRB	2022 Year 10 Month 24 Day
Anticipated trial start date	2022 Year 11 Month 01 Day
Last follow-up date	2027 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2028 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2022 Year 10 Month 28 Day
Last modified on	2022 Year 11 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056181