UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040176 |
|---|---|
| Receipt number | R000045803 |
| Scientific Title | Investigation of the mechanism of acquiring oral tolerance and its application to diagnosis/treatment |
| Date of disclosure of the study information | 2020/04/16 |
| Last modified on | 2025/04/23 08:59:51 |
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Basic information
Public title
Investigation of the mechanism of acquiring oral tolerance and its application to diagnosis/treatment
Acronym
Investigation of the mechanism of acquiring oral tolerance and its application to diagnosis/treatment
Scientific Title
Investigation of the mechanism of acquiring oral tolerance and its application to diagnosis/treatment
Scientific Title:Acronym
Investigation of the mechanism of acquiring oral tolerance and its application to diagnosis/treatment
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To evaluate the efficacy and safety of oral immunotherapy.
2) To determine biomarkers for oral tolerance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Unresponsiveness to orally ingested allergens
Key secondary outcomes
Allergen-specific immunoglobulins (IgG4/IgE/IgA), Lymphocyte function
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Single-arm study. The intervention is to take certain allergens orally for 3-5 years.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Food allergy patients diagnosed by oral food challenge test.
2) Patients who agreed to participate in this study with written consent.
3) The analysis also includes patient specimens who underwent oral immunotherapy from 2011 to April 2020.
Key exclusion criteria
1) Patients with serious chronic diseases such as malignant tumors or immunodeficiency.
2) Patients who are not eligible for adrenaline self-injection.
3) Patients who the investigator judged to be unsuitable for the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Yasutomi |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Pediatrics
Zip code
910-1193
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL
0776(61)3111
yasutomi@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Motoko |
| Middle name | |
| Last name | Yasutomi |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Pediatrics
Zip code
910-1193
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL
0776(61)3111
Homepage URL
yasutomi@u-fukui.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Faculty of Medical Sciences, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Self funding, partly from Japan Agency for Medical Research and Development.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kanazawa University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Faculty of Medical Sciences, University of Fukui
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
Tel
0776(61)8614
sm-kenkyusien@ml.u-fukui.ac.jp
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
| 2020 | Year | 04 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2035 | 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
| 2020 | Year | 04 | Month | 16 | Day |
Last modified on
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045803
