UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002958 |
|---|---|
| Receipt number | R000003598 |
| Scientific Title | The oral tolerance induction by the fermented soybean (natto) in soybean allergy |
| Date of disclosure of the study information | 2010/07/01 |
| Last modified on | 2009/12/30 18:13:45 |
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Basic information
Public title
The oral tolerance induction by the fermented soybean (natto) in soybean allergy
Acronym
The oral tolerance induction by the fermented soybean
Scientific Title
The oral tolerance induction by the fermented soybean (natto) in soybean allergy
Scientific Title:Acronym
The oral tolerance induction by the fermented soybean
Region
| Japan |
Condition
Condition
food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the intake of fermented soybean induce the tolerance of the patients with soybean allergy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The tolerance induction of the patients with soybean allergy by taking fermented soybean.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 6 | months-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient with soybean allergy who show the allergic reaction to soybean.
Key exclusion criteria
The patient with soybean allergy who have intolerable reaction to fermented soybean.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naomi Kondo |
Organization
Graduate School of Medicine, Gifu University
Division name
Department of Pediatrics
Zip code
Address
1-1 Yanagido, Gifu
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Medicine, Gifu University
Division name
Department of Pediatrics
Zip code
Address
TEL
Homepage URL
hideo@gifu-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Gifu University
Institute
Department
Personal name
Funding Source
Organization
Reserach and Developmental Program for New Bio-industry Initiatives
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
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
| 2010 | Year | 07 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The patients with soybean allergy are challenged by the intake of low-dose fermented soybean. Then, the dose are gradually increaed.
Management information
Registered date
| 2009 | Year | 12 | Month | 30 | Day |
Last modified on
| 2009 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003598
