UMIN-CTR Clinical Trial

Basic information
Public title	Low-dose oral immunotherapy for food allergies (buckwheat, fruits, walnuts, cashews, hazelnuts, and macadamia nuts).
Acronym	Low-dose oral immunotherapy
Scientific Title	Low-dose oral immunotherapy for food allergies (buckwheat, fruits, walnuts, cashews, hazelnuts, and macadamia nuts).
Scientific Title:Acronym	Low-dose oral immunotherapy
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of low-dose oral immunotherapy for food allergies.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The rate of short-term unresponsiveness* to the middle-dose** after 1 year * Short-term unresponsiveness is defined as "when patients passed the middle-dose oral food challenge after complete avoidance for 2 weeks." ** The middle-dose is defined as "16 g buckwheat noodle, 40 g fruits, and 3 g walnuts, cashews, hazelnuts, and macadamia nuts."
Key secondary outcomes	1. Frequency of adverse reactions 2. The rate of short-term unresponsiveness* to the middle-dose** after 2 years, 3 years, 4 years, and 5 years from the start of oral immunotherapy(OIT) 3. Changes of specific IgE, IgG, and IgG4 * Short-term unresponsiveness is defined as "when patients passed the middle-dose oral food challenge after complete avoidance for 2 weeks." ** The middle-dose is defined as "16 g buckwheat noodle, 40 g fruits, and 3 g walnuts, cashews, hazelnuts, and macadamia nuts."

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	1.The target amount of ingestion is defined as 2 g buckwheat noodle, 10 g fruits, and 0.5 g walnuts, cashews, hazelnuts, and macadamia nuts. 2.The subjects are asked to take a small amount of their causative food at the inpatient department. The amount is gradually built up to their target amount depending on their symptoms. 3.The subjects continue to ingest their causative foods for a year after discharge from the hospital.
Interventions/Control_2
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	1 years-old <=
Age-upper limit	18 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who visited our hospital and exhibited objective symptoms based on the oral food challenge with one of the following food products are included in this study; 2 g buckwheat noodle (100 mg buckwheat protein), 5 g fruits, 0.5 g walnuts (75 mg walnut protein), 0.5 g cashews (90 mg cashew protein), 0.5 g hazelnuts (75 mg hazelnut protein), and 0.5 g macadamia nuts (45 mg macadamia nut protein). Objective symptoms were based on the Japanese Society of Allergology anaphylaxis guidelines (Yanagida N. et al. Allergol Int 2016, Ebisawa M. et al. Allergol Int 2017.).
Key exclusion criteria	1.The subject who has poorly treated atopic dermatitis and bronchial asthma. 2.The subject who seems inappropriate candidate for oral immunotherapy as judged by a medical doctor.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Motohiro Middle name Last name Ebisawa
Organization	National Hospital Organization Sagamihara National Hospital
Division name	Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code	252-0392
Address	18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.
TEL	042-742-8311
Email	mebisawa@foodallergy.jp

Public contact
Name of contact person	1st name Noriyuki Middle name Last name Yanagida
Organization	National Hospital Organization Sagamihara National Hospital
Division name	Clinical Research Center for Allergy and Rheumatology
Zip code	252-0392
Address	18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.
TEL	042-742-8311
Homepage URL
Email	yana@foodallergy.jp

Sponsor
Institute	National Hospital Organization Sagamihara National Hospital
Institute
Department

Funding Source
Organization	Self funding
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	National Hospital Organization Sagamihara National Hospital
Address	18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.
Tel	042-742-8311
Email	222-rinri@mail.hosp.go.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	2020 Year 05 Month 26 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	2015 Year 10 Month 01 Day
Date of IRB	2015 Year 11 Month 17 Day
Anticipated trial start date	2015 Year 11 Month 17 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 05 Month 26 Day
Last modified on	2020 Year 11 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046267