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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024700
Receipt No. R000028419
Scientific Title Verification of suppressing effects of Japanese cedar pollen peptide-containing rice on symptoms and IgE associated with Japanese cedar pollinosis (Study 2)
Date of disclosure of the study information 2016/11/04
Last modified on 2018/12/03

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Basic information
Public title Verification of suppressing effects of Japanese cedar pollen peptide-containing rice on symptoms and IgE associated with Japanese cedar pollinosis (Study 2)
Acronym Verification of suppressing effect of Japanese cedar pollen peptide-containing rice on Japanese cedar pollen-specific IgE
Scientific Title Verification of suppressing effects of Japanese cedar pollen peptide-containing rice on symptoms and IgE associated with Japanese cedar pollinosis (Study 2)
Scientific Title:Acronym Verification of suppressing effect of Japanese cedar pollen peptide-containing rice on Japanese cedar pollen-specific IgE
Region
Japan

Condition
Condition Japanese cedar pollinosis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Verification of suppressing effect of Japanese cedar pollen peptide-containing rice on Japanese cedar pollen-specific IgE
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes serum Japanese cedar pollen-specific IgE antibody level at 0, 12, 24, 36 48, 60, 72, 84, 96weeks after the stat of ingestion
Key secondary outcomes 1)Japanese cedar pollen-specific T cell proliferative response at at 0, 12, 24, 36 48, 60, 72, 84, 96weeks after the stat of ingestion
2)Adverse events from the start to the end of ingestion

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Japanese cedar pollen allergy relief rice 5g intake group (allergy rerief rice 5g plus pracebo rice 45g once a day, for 96 weeks, 10 cases)
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
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1)those who have presented with symptoms related allergic rhinitis such as sneezing, nasal discharge, obstruction and eye itching for at least 2continuous years, consistent with the cedar pollen season
2)those whose Japanese cedar pollen allergen-specific IgE antibody titer show class the 2 or more (measured by AlaSTAT 3g method)
3)those whose Japanese cypress pollen-specific IgE antibody titer show the class 4 or less (AlaSTAT 3g)
4)those who live or work in Osaka prefecture and consented to research participation by the document from the person obtained
5)those who can comply with not to transfer the test product to a third party
Key exclusion criteria 1)those whom Principal Investigator or the sharing researchers have determined inappropriate
2)those who suffer from rice allergy or have a history of rice allergy
3)those whose pets (dogs, cats) and house dust and mite-specific IgE antibody titers show the class of 5 or more, ond who are breeding a pet.
4)those whose house dust and mite-specific IgE antibody titer, swow higher than the cedar pollen-specific IgE antibody titers
5)those who have received immunotherapy for cedar pollen, or have the schedule
6)those who suffer from some serious disease with disease activity, therefore, are judged unsuitable for enrolement by the clinician
7)those who are or planning to become pregnant or in the process of breast-feeding during the clinical reseach
8)those who are participating in other clinical research
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoji Hashimoto
Organization Osaka Habikino Medical Center
Division name Clinical Reseach Center
Zip code
Address 3-7-1 Habikino Habikino city Osaka
TEL 072-957-2121
Email hashisyo@ra.opho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shoji Hashimoto
Organization Osaka Habikino Medical Center
Division name Clinical Reseach Center
Zip code
Address 3-7-1 Habikino Habikino city Osaka
TEL 072-957-2121
Homepage URL
Email hashisyo@ra.opho.jp

Sponsor
Institute Osaka Habikino Medical Center
Institute
Department

Funding Source
Organization Osaka Habikino Medical Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Clinical Application of Biologics, Osaka University Graduate School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 (地独)大阪はびきの医療センター

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 04 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 No longer recruiting
Date of protocol fixation
2016 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 03 Day
Last modified on
2018 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028419

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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