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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009688
Receipt No. R000011211
Scientific Title A physician-initiated translation of independent single-blind research for rice-based oral cholera vaccine, MucoRice-CTB in healthy volunteers
Date of disclosure of the study information 2013/01/22
Last modified on 2013/04/11

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Basic information
Public title A physician-initiated translation of independent single-blind research for rice-based oral cholera vaccine, MucoRice-CTB in healthy volunteers
Acronym A physician-initiated independent translation research for MucoRice-CTB in healthy volunteers
Scientific Title A physician-initiated translation of independent single-blind research for rice-based oral cholera vaccine, MucoRice-CTB in healthy volunteers
Scientific Title:Acronym A physician-initiated independent translation research for MucoRice-CTB in healthy volunteers
Region
Japan

Condition
Condition Cholera, Traveler's diarrhea
Classification by specialty
Medicine in general Gastroenterology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A clinical research for rice-based oral vaccine, MucoRice-CTB to obtain POC in healthy volunteers
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1)CTB-specific serum IgG/IgA and CTB-specific fecal IgA immune responses
(2)Safety issue: Rice-specific serum IgE immune response
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Vaccine
Interventions/Control_1 Test group(N=10)
MucoRice-CTB (rice powder 750mg containing 1mg of CTB)
Interventions/Control_2 Control group(N=10)
Wild –type rice (rice powder 750mg)
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
40 years-old >=
Gender Male
Key inclusion criteria Healthy male
Age between 20 to 40
Negative test for anti-CT fecal IgA
No severe hepatological, renal or hematological disorder
No severe heart disease
No medications
Able and willing to give valid written informed consent
Key exclusion criteria Rice allergy
Past history of cholera or traveler's diarrhea
Severe constipation
Decision of unsuitableness by principal investigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Ohno
Organization IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Division name Department of Advanced Medical Science
Zip code
Address 4-6-1, Shirokanedai, Minato-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Division name Department of Advanced Medical Science
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Institute
Department

Funding Source
Organization New Energy and Industrial Technology Development Organization
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 22 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
2012 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 22 Day
Last follow-up date
2013 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
2013 Year 01 Month 04 Day
Last modified on
2013 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011211

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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