UMIN-CTR Clinical Trial

Basic information
Public title	Elucidation of the mechanism of oral tolerance induction to the transgenic rice containing peptides from Japanese cedar pollen allergens and the efficacy of long-term administration.
Acronym	Elucidation of the mechanism of oral tolerance induction to the transgenic rice containing peptides from Japanese cedar pollen allergens and the efficacy of long-term administration.
Scientific Title	Elucidation of the mechanism of oral tolerance induction to the transgenic rice containing peptides from Japanese cedar pollen allergens and the efficacy of long-term administration.
Scientific Title:Acronym	Elucidation of the mechanism of oral tolerance induction to the transgenic rice containing peptides from Japanese cedar pollen allergens and the efficacy of long-term administration.
Region	Japan

Condition
Condition	Japanese cedar pollinosis
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Long-term administration of the transgenic rice containing peptides from Japanese cedar pollen allergens and elucidation of the mechanism of oral tolerance induction.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subjective symptoms -Scoring of allergy diaries between placebo group and transgenic rice group are compared
Key secondary outcomes	1.Surveys on lifestyles 2.JRQLQ 3.Intranasal observation with rhinoscopy 4.Intradermal reaction, number of nasal eosinophil, total serum IgE and cedar pollen-specific IgE 5.Immunological test:Evaluation of T-cell responses to 7crp, Cry j 1 and cry j 2. 6.Examination of height, weight, BMI,body temperature,blood pressure and pulse count 7.Safety (adverse events)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Evaluation of the efficacy of oral administration group of 20g of transgenic rice for 24 weeks
Interventions/Control_2	Evaluation of the efficacy of oral administration group of 5g of transgenic rice for 24 weeks
Interventions/Control_3	Evaluation of the efficacy of oral administration group of 50g of placebo rice for 24 weeks
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) Adult aged over 20years old and under 70years old and lives or works near The Jikei University School of Medicine. 2) A person who has allergic symptoms such as sneezing, running nose, and nasal obstruction. 3) A person who gives a positive result in provocative test and intradermal test (please refer to appendix for an assessment procedures) 4) Cedar pollen allergen-specific IgE antibody values over Class II. 5) Cypress specific IgE antibody values under Class IV. 6) Stimulation index of T-cell response to allergens over 2.0.
Key exclusion criteria	1) A person who is allergic to Rice or has a history of Rice allergy. 2) A person who shows House dust specific IgE antibody valued over Class V, and has chronic rhinitis 3) A person who is imperative to use medicine such as anti-allergic agent and steroidal chemicals that potentially influence the outcome of evaluation. 4) A person who underwent an operation that is accompanied to nasal disorder within last 2years, or has nasal disorder such as acute/chronic-rhinitis, rhinopolypus, hypertronic rhinitis, septal deviation, sinusitis which all are potentially hinder to the outcome of evaluation. 5) A person who has any disorders under treatment and the condition is unstable that trial investigator has asessed as mismatched participant. 6) A person who has a history of serious disorder such as diabetes, hepatic disorder, kidney disorder, and cardiac disorder. 7) A person who takes beta-blocker in order to treat complecating disorders such as hypertension, and / or cardiac disorder. 8) A person who takes alpha-blocker in order to treat complecating disorders such as prostatic hyperplasia. 9) A person who is complecated by immunodeficiency disorder, cancer, or severe enemia. 10) A person who is complecated by asthma. 11) A person who has laboratory abnormalities in the pre-clinical test that trial investigator has assessed as mismatched participant. 12) A person already in another clinical test when this clinical test begins. 13) A person who is presently breastfeeding, pregnant, or planning/wishing to be a pregnant during a period of this clinical test. 14) A person whom trial investigator has asessed as mismatched participant.
Target sample size	45

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Daiya Asaka
Organization	The Jikei University School of Medicine
Division name	Department of Otorhinolaryngology
Zip code
Address	3-25-8 Nishi Shinbashi, Minato-ku, Tokyo, 105-8461
TEL	03-3433-1111
Email	asaka@jikei.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Daiya Asaka
Organization	The Jikei University School of Medicine
Division name	Department of Otorhinolaryngology
Zip code
Address	3-25-8 Nishi Shinbashi, Minato-ku, Tokyo, 105-8461
TEL	03-3433-1111
Homepage URL
Email	asaka@jikei.ac.jp

Sponsor
Institute	The Jikei University School of Medicine
Institute
Department

Funding Source
Organization	The Jikei University School of Medicine
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
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	東京慈恵会医科大学附属病院

Other administrative information
Date of disclosure of the study information	2018 Year 09 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	Completed
Date of protocol fixation	2016 Year 10 Month 18 Day
Date of IRB	2016 Year 10 Month 12 Day
Anticipated trial start date	2016 Year 11 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 09 Month 26 Day
Last modified on	2019 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039074