UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023453 |
|---|---|
| Receipt number | R000027004 |
| Scientific Title | Clinical Studies of mechanism on oral tolerance induction by slow oral immunothrapy |
| Date of disclosure of the study information | 2016/08/13 |
| Last modified on | 2020/08/08 16:32:44 |
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Basic information
Public title
Clinical Studies of mechanism on oral tolerance induction by slow oral immunothrapy
Acronym
Clinical Studies on oral tolerance induction by slow oral immunothrapy
Scientific Title
Clinical Studies of mechanism on oral tolerance induction by slow oral immunothrapy
Scientific Title:Acronym
Clinical Studies on oral tolerance induction by slow oral immunothrapy
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal mechanism of oral tolerance induction
Basic objectives2
Others
Basic objectives -Others
validation of the difference of immunoglobulin dynamics between Successful and non-successful
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Validation of Salava specific IgA for three years
Key secondary outcomes
Validation of Serum specific IgE for three years
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
allergen foods are slowly increasing to the target amount and continuing its amount until tolerance induction.
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
| 5 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
food allergy patients who wish to join this study at the age of five or more.
Key exclusion criteria
1; Patients using beta-blockers, 2; patients who are pregnant at the time of the start of treatment, 3; Patient who has the unstable severe asthma, 4; Patients with systemically serious disease (malignant tumors, autoimmune diseases, immune deficiencies, severe heart disease, chronic infections, etc.), 5; patients using continuous use systemic corticosteroids or anti-cancer agents, and 6; Patients who are suffering from acute infection.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasuto |
| Middle name | |
| Last name | Kondo |
Organization
Fujita Health University, Second teaching Hospital
Division name
Department of Pediatrics, School of Medicine
Zip code
454-8509
Address
3-6-10, Otoubashi, Nakagawa, Nagoya
TEL
052-323-5649
ykondo@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Yasuto |
| Middle name | |
| Last name | Kondo |
Organization
Fujita Health University, Second teaching Hospital
Division name
Department of Pediatrics
Zip code
454-8509
Address
3-6-10, Otoubashi, Nakagawa, Nagoya
TEL
052-323-5649
Homepage URL
ykondo@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Pediatrics, School of Medicine, Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Department of Pediatrics, School of Medicine, Fujita Health University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyoto College of Nutritional & Medical Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health Uninersity
Address
1-98 Dengakugakubo Kutsukake, Toyoake, Aichi, Japan
Tel
0562-93-2865
irb-sys@fujita-hu.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
| 2016 | Year | 08 | Month | 13 | 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
| 2016 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2016 | Year | 08 | Month | 02 | Day |
Last modified on
| 2020 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027004
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
