Unique ID issued by UMIN | UMIN000009688 |
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Receipt number | 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 19:18:44 |
A physician-initiated translation of independent single-blind research for rice-based oral cholera vaccine, MucoRice-CTB in healthy volunteers
A physician-initiated independent translation research for MucoRice-CTB in healthy volunteers
A physician-initiated translation of independent single-blind research for rice-based oral cholera vaccine, MucoRice-CTB in healthy volunteers
A physician-initiated independent translation research for MucoRice-CTB in healthy volunteers
Japan |
Cholera, Traveler's diarrhea
Medicine in general | Gastroenterology | Infectious disease |
Others
NO
A clinical research for rice-based oral vaccine, MucoRice-CTB to obtain POC in healthy volunteers
Safety,Efficacy
(1)CTB-specific serum IgG/IgA and CTB-specific fecal IgA immune responses
(2)Safety issue: Rice-specific serum IgE immune response
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Placebo
2
Prevention
Vaccine |
Test group(N=10)
MucoRice-CTB (rice powder 750mg containing 1mg of CTB)
Control group(N=10)
Wild –type rice (rice powder 750mg)
20 | years-old | <= |
40 | years-old | >= |
Male
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
Rice allergy
Past history of cholera or traveler's diarrhea
Severe constipation
Decision of unsuitableness by principal investigator
20
1st name | |
Middle name | |
Last name | Hideki Ohno |
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Department of Advanced Medical Science
4-6-1, Shirokanedai, Minato-ku, Tokyo, Japan
1st name | |
Middle name | |
Last name |
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Department of Advanced Medical Science
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
New Energy and Industrial Technology Development Organization
NO
2013 | Year | 01 | Month | 22 | Day |
Unpublished
Completed
2012 | Year | 12 | Month | 26 | Day |
2013 | Year | 01 | Month | 22 | Day |
2013 | Year | 03 | Month | 31 | Day |
2013 | Year | 01 | Month | 04 | Day |
2013 | Year | 04 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011211
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