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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042856
Receipt No. R000048918
Scientific Title Efficacy of stepwise oral food challenge in children suspected of peanut allergy
Date of disclosure of the study information 2020/12/25
Last modified on 2020/12/25

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Basic information
Public title Stepwise peanut oral food challenge
Acronym Stepwise peanut oral food challenge
Scientific Title Efficacy of stepwise oral food challenge in children suspected of peanut allergy
Scientific Title:Acronym Stepwise peanut oral food challenge
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 stepwise peanut oral food challenge
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 positive oral food challenge

The rate of anaphylaxis induced by oral food challenge
Key secondary outcomes Reproducibility of negative or uncertain oral food challenge results at home
The change in peanut, Ara h 2 specific IgE levels

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Food
Interventions/Control_1 Patients suspected of peanut allergy receive stepwise oral food challenge.
Patients with Ara h 2 specific IgE greater than 4.0 kUA/L start with a very low dose oral food challenge.
Patients with Ara h 2 specific IgE less than 4.0 kUA/L and have a past history of immediate type reaction start with low dose oral food challenge.
Patients with Ara h 2 specific IgE less than 4.0 kUA/L and have no history of immediate reaction start with middle dose oral food challenge.

Very low dose oral food challenge;
oral food challenge with 0.12g of peanut powder

Low dose oral food challenge; oral food challenge with 0.5g of peanut or peanut powder contained in foods such as pumpkin cake and hamburger steak

Middle dose oral food challenge; oral food challenge with 3g of peanut or peanut powder contained in foods such as pumpkin cake and hamburger steak

Full dose oral food challenge; oral food challenge with 10g of peanut or peanut powder contained in foods such as pumpkin cake and hamburger steak

The patients who pass each oral food challenge receive next oral food challenge if the results are negative.

All oral food challenges are performed in a single dose or in two doses.
In the two-dose oral food challenges, challenged foods are administered in a 60 min interval.

The patients classified as negative or uncertain in very low dose oral food challenge are then given 0.12g of peanut powder and instructed to consume it >2 times at home.

The patients classified as negative or uncertain in low dose or middle dose or full dose oral food challenge are instructed to consume the same amount >2 times at home.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who receive peanut oral food challenges at our hospital
Key exclusion criteria The subjects who are undergoing oral immunotherapy or epicutaneous immunotherapy
The subjects who disagree to participate in the study
The subjects judged inappropriate for the study by the research director
Target sample size 172

Research contact person
Name of lead principal investigator
1st name Noriyuki
Middle name
Last name Yanagida
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of Pediatrics
Zip code 252-0392
Address 18-1, Sakuradai, Minamiku, Sagamiharashi, Kanagawa, Japan
TEL 042-742-8311
Email yana@foodallergy.jp

Public contact
Name of contact person
1st name Ken-ichi
Middle name
Last name Nagakura
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of Pediatrics
Zip code 252-0392
Address 18-1, Sakuradai, Minamiku, Sagamiharashi, Kanagawa, Japan
TEL 042-742-8311
Homepage URL
Email k.nagakura@foodallergy.jp

Sponsor
Institute National Hospital Organization Sagamihara National Hospital
Institute
Department

Funding Source
Organization none
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 National Hospital Organization Sagamihara National Hospital
Address 18-1, Sakuradai, Minami-ku, Sagamihara, Kanagawa 252-0392, Japan
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 12 Month 25 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
2020 Year 10 Month 08 Day
Date of IRB
2020 Year 11 Month 18 Day
Anticipated trial start date
2020 Year 12 Month 25 Day
Last follow-up date
2040 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 12 Month 25 Day
Last modified on
2020 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048918

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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