UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022826 |
|---|---|
| Receipt number | R000026259 |
| Scientific Title | Supplemental effect of fermented soy product on rush oral immunotherapy (F-SOI)- Double blind - randomized placebo control trial - |
| Date of disclosure of the study information | 2016/06/21 |
| Last modified on | 2018/06/29 13:46:34 |
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Basic information
Public title
Supplemental effect of fermented soy product on rush oral immunotherapy (F-SOI)- Double blind - randomized placebo control trial -
Acronym
F-SOI
Scientific Title
Supplemental effect of fermented soy product on rush oral immunotherapy (F-SOI)- Double blind - randomized placebo control trial -
Scientific Title:Acronym
F-SOI
Region
| Japan |
Condition
Condition
food allergy
Classification by specialty
| Clinical immunology | Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of combined therapy comprising fermanted soy product with rush oral immunotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The total score of allergic reaction score plus rescue drug score during rash phase of OIT.
Key secondary outcomes
The amount of food consumption and the proportion of patients who reached the target dose (20g of boiled egg, 100ml of milk and 100g of udon noodle) at discharge and at 3 months after discharge.
The changes in value of laboratory data (e.g. specific IgE titer)
The changes in value of the threshold dose of antigen and severity of allergic reaction provoked in OFCs
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
the consumption of 600mg/day fermanted soy product from 1~2 month before ROIT to 3 months after the end of rash phase of OIT
Interventions/Control_2
the consumption of plasebo from 1~2 month before starting ROIT until 3 month after the end of rash phase of OIT
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
| 5 | years-old | < |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patient with severe food allergy for egg, milk, wheat diagnosed by oral food challenge
Key exclusion criteria
patients with severe comorbidity
patients with uncontrollable asthma or atopic dermatitis
patients with severe food allergy for soybeans
patients whom the doctor assess ineligible
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Komei Ito |
Organization
Aichi Children's Health and Medical Center
Division name
Department of Allergy
Zip code
Address
7-426, Morioka, Obu, Aichi 474-8710, Japan
TEL
0562-43-0500
koumei_itoh@mx.achmc.pref.aichi.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Iwao Tajima |
Organization
Aichi Children's Health and Medical Center
Division name
Department of Allergy
Zip code
Address
7-426, Morioka, Obu, Aichi 474-8710, Japan
TEL
0562-43-0500
Homepage URL
iwao_tajima@sk00106.achmc.pref.aichi.jp
Sponsor or person
Institute
Aichi Children's Health and Medical Center
Institute
Department
Personal name
Funding Source
Organization
NICHIMO BIOTICS Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
あいち小児保健医療総合センター(愛知県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 21 | 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 | 03 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 21 | Day |
Last modified on
| 2018 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026259
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
