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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035603
Receipt No. R000040570
Scientific Title Analysis of the efficacy of oral immunotherapy combined with brown rice-specific gamma-oryzanol for children with food allergy
Date of disclosure of the study information 2019/01/21
Last modified on 2019/07/23

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Basic information
Public title Analysis of the efficacy of oral immunotherapy combined with brown rice-specific gamma-oryzanol for children with food allergy
Acronym Analysis of the efficacy of oral immunotherapy combined with brown rice-specific gamma-oryzanol
Scientific Title Analysis of the efficacy of oral immunotherapy combined with brown rice-specific gamma-oryzanol for children with food allergy
Scientific Title:Acronym Analysis of the efficacy of oral immunotherapy combined with brown rice-specific gamma-oryzanol
Region
Japan

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

Objectives
Narrative objectives1 To investigate the efficacy of gamma-oryzanol for children with food allergy
Gamma-oryzanol is a brewed non-alcoholic beverage derived from brown rice
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sustained unresponsiveness to middle-dose after 12 months.
Middle dose was defined as "half of a whole egg, 25 ml of cow's milk, 25g of Udon, 3g of peanut or 3g of nut".
Key secondary outcomes Intestinal microbiota
Short chain fatty acids (Acetic acid, butyric acid, propionic acid, valeric acid) in serum
Changes of specific IgE, IgG, IgG4
Frequency of adverse reactions

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 Patient ingests brown rice-specific gamma-oryzanol for 1 year
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
5 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria Patients who failed low-dose oral food challenge
Low-dose was defined as "one eight of whole egg, 3 ml of cow's milk, 2g of Udon (Japanese wheat noodles), 0.5g of whole peanut or 0.5g of nut".
Key exclusion criteria Decision of ineligibility by a physician
Target sample size 15

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, Sagamihara City, Kanagawa, Japan, 252-0392
TEL 042-742-8311
Email Ssakura8010@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, Sagamihara City, Kanagawa, Japan, 252-0392
TEL 042-742-8311
Homepage URL
Email k.nagakura@foodallergy.jp

Sponsor
Institute National Hospital Organization Sagamihara National Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Second Department of Internal Medicine, Graduate School of Medicine, University of the Ryukyus
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization Sagamihara National Hospital
Address 18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
Tel 042-742-8311
Email furuta.harumi.we@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
2019 Year 01 Month 21 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 Enrolling by invitation
Date of protocol fixation
2019 Year 01 Month 01 Day
Date of IRB
2018 Year 05 Month 15 Day
Anticipated trial start date
2019 Year 01 Month 21 Day
Last follow-up date
2021 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
2019 Year 01 Month 21 Day
Last modified on
2019 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040570

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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