UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009688
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

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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