UMIN-CTR Clinical Trial

Basic information
Public title	Safety of small-dose introduction and stepwise increases for induction of tolerance in children with hen's egg allergy: a single center randomized double-blind parallel-group phase II trial
Acronym	Safety of small-dose introduction and stepwise increases in children with hen's egg allergy (STITCH): a randomized double-blind parallel-group trial
Scientific Title	Safety of small-dose introduction and stepwise increases for tolerance induction in children with hen's egg allergy: a single center randomized double-blind parallel-group phase II trial
Scientific Title:Acronym	A randomized trial to investigate safety of small-dose introduction for children with hen's egg allergy (STITCH)
Region	Japan

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

Objectives
Narrative objectives1	To investigate whether very small amount of starting method is safer than fixed-quantity maintenance method by randomized double-blind parallel-group trial on hen's egg introduction
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time to onset of IgE-dependent immediate reaction after starting the experimental diet
Key secondary outcomes	1.Secondary outcomes on effectiveness: (1) Change in cumulative tolerated dose on formal registration day to at 24 and 48 weeks after starting the experimental diet (2) Whether the oral challenge test of hen's egg is negative at 24 and 48 weeks after starting the experimental diet (3) Change in total IgE value on temporary registration day to that at 24 and 48 weeks after starting the experimental diet (4) Change in egg white- and ovomucoid-specific IgE value on temporary registration day to that at 24 and 48 weeks after starting the experimental diet (5) Change in egg white- and ovomucoid-specific IgG4 value on temporary registration day to that at 24 and 48 weeks after starting the experimental diet (6) Change in urinary PGDM (tetranor-PGDM, tetranor-PGEM) value 4 h after the intake of experimental diet on the starting day and at 4, 12, 24, 36, and 48 weeks (7) Ratio of urinary PGDM (tetranor-PGDM, tetranor-PGEM) value before and 4 h after the intake of experimental diet on the starting day and at 4, 12, 24, 36, and 48 weeks (8) Change in difference of urinary PGDM (tetranor-PGDM, tetranor-PGEM) value between before and 4 h after the intake of experimental diet on the starting day and at 4, 12, 24, 36, and 48 weeks 2.Secondary outcomes on safety: (1) The maximum severity score of IgE-dependent immediate-type allergic reaction against hen's egg caused by experimental diet (2) Number of symptom days related to IgE-dependent immediate-type allergic reaction against hen's egg (3) Presence or absence of anaphylaxis related to the experimental diet (4) Presence or absence of emergency room visits related to the experimental diet (5) Number and proportion of participants who experienced severe adverse reactions at least once (6) Number of participants who experienced severe adverse reactions, reaction appearance rate, and number of reactions (Continued in "Other related information")

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	1.Very small amount at the starting method (The experimental therapy group) -We set a cumulative tolerated dose of the hen's egg intake by oral challenge test on formal registration day. -Patients take in the experimental diet including the hen's egg (egg white and yolk) of 1/50 quantity of the cumulative tolerated dose the day after the initiation for 4 weeks. -Patients take in the experimental diet including the hen's egg of 1/10 quantity of the cumulative tolerated dose the day after from 4 to 8 weeks. -Patients take in the experimental diet including the hen's egg of half quantity of the cumulative tolerated dose the day after from 8 to 12 weeks. -Patients take in the experimental diet including the hen's egg of a cumulative tolerated dose the day after from 12 to 48 weeks.
Interventions/Control_2	2.Fixed-quantity maintenance method (Standard therapy group) -We set a cumulative tolerated dose of the hen's egg intake by oral challenge test on formal registration day. -Patients take in the experimental diet including the hen's egg of a cumulative tolerated dose every day until 48 weeks later.
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	Inclusion criteria for temporary registration: (1)Patients diagnosed with hen's egg allergy or suspected of hen's egg allergy (egg white-specific IgE >= 0.35 kUA/L) by a medical doctor from up to 1 year before the temporary registration date (2)Aged 1-18 years (3)Informed written consent from patients or authorized guardians (patients aged >= 16 years gave their own written consent) Inclusion criteria for formal registration: (1)Patients temporarily registered who fulfill the inclusion criteria and do not conflict with the exclusion criteria for temporary registration, including the formal registration day (2)Patients diagnosed with hen's egg allergy by an oral challenge test with 10 g of a hen's egg (egg white and yolk) within 60 days after temporary registration (3)Patients with a cumulative tolerated dose of hen's egg determined by an oral challenge test with 10 g of a hen's egg (egg white and yolk)
Key exclusion criteria	Exclusion criteria for temporary registration: (1)Patients born before 37 weeks of gestation (2)Patients with siblings already enrolled (3)Immunosuppressant or systemic steroid administration (4)Patients planning to relocate or having difficulty making regular visits to our facility (5)Patients with severe complications (6)Allergy to rice, pumpkin, sugar beet, palm oil, cornstarch, baking powder, sweet potato, or trehalose (7)Patients considered unsuitable for the study by the lead researcher or co-researchers for other reasons
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Fumi Middle name Last name Ishikawa
Organization	National Center for Child Health and Development
Division name	Allergy Center
Zip code	157-8535
Address	2-10-1,Okura,Setagayaku,Tokyo 157-8535,Japan
TEL	0334160181
Email	allergy_research@ncchd.go.jp

Public contact
Name of contact person	1st name Kiwako Middle name Last name Yamamoto-Hanada
Organization	National Center for Child Health and Development
Division name	Allergy Center
Zip code	157-8535
Address	2-10-1,Okura,Setagayaku,Tokyo 157-8535,Japan
TEL	0334160181
Homepage URL
Email	allergy_research@ncchd.go.jp

Sponsor
Institute	National Center for Child Health and Development
Institute
Department

Funding Source
Organization	National Center for Child Health and Development
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	IRB of National Center for Child Health and Development
Address	2-10-1,Okura,Setagayaku,Tokyo 157-8535,Japan
Tel	0334160181
Email	rinri@ncchd.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	2021 Year 02 Month 24 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	Preinitiation
Date of protocol fixation	2021 Year 02 Month 01 Day
Date of IRB	2021 Year 02 Month 01 Day
Anticipated trial start date	2021 Year 03 Month 01 Day
Last follow-up date	2024 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

(Continuation of "Key secondary outcomes") 3. Secondary outcomes on adherence and others: (1) Days of experimental diet intake from starting day to 48 weeks after (2) Whether good adherence or not after 48 weeks of starting the experimental diet (3) VAS scale in the participant's resistance against experimental diet on starting day and at 4, 12, 24, 36, and 48 weeks (4) FAQLQ score on the experimental diet on starting day and at 4, 12, 24, 36, and 48 weeks (5) Atopic dermatitis severity score (EASI) on the starting day and at 4, 12, 24, 36, and 48 weeks (6) Number of episodes of asthmatic exacerbation during the trial (7) Presence or absence of non-IgE-mediated gastrointestinal allergy during the trial

Management information
Registered date	2021 Year 02 Month 17 Day
Last modified on	2021 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049497

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
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