UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041561 |
|---|---|
| Receipt number | R000047454 |
| Scientific Title | Simultaneously slow low dose oral immunotherapy |
| Date of disclosure of the study information | 2020/08/26 |
| Last modified on | 2024/03/04 15:42:39 |
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Basic information
Public title
Simultaneously slow low dose oral immunotherapy
Acronym
double S-LOIT
Scientific Title
Simultaneously slow low dose oral immunotherapy
Scientific Title:Acronym
double S-LOIT
Region
| Japan |
Condition
Condition
Children who have multiple severe food allergies among hen's egg, cow's milk, wheat.
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of double S-OIT
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The result of oral food challenges after one-year of double S-OIT
Key secondary outcomes
feasibility of double S-LOIT
safety of double S-LOIT
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Simultaneously slow low dose oral immunotherapy
(ingesting Mikotama-cookie everyday with increaseing the dose at home whenever they could for every 30 consecutive intakes without obvious allergic symptoms)
compared with historical control (complete avoidance of antigen)
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
| 3 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Children with multiple severe food allergies to hen's egg, cow's milk, or wheat whose symptom-provoked total dose in the OFC 3.7g (mL) or lower.
Key exclusion criteria
uncontrolled bronchial asthma or atopic dermatitis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shiro |
| Middle name | |
| Last name | Sugiura |
Organization
Aichi Children's Health and Medical Center
Division name
Department of Allergy
Zip code
474-8710
Address
7-426, Morioka, Obu, Aichi 474-8710, Japan
TEL
0562-43-0500
bee_jayz@hotmail.com
Public contact
Name of contact person
| 1st name | Shiro |
| Middle name | |
| Last name | Sugiura |
Organization
Aichi Children's Health and Medical Center
Division name
Department of Allergy
Zip code
474-8710
Address
7-426, Morioka, Obu, Aichi 474-8710, Japan
TEL
0562-43-0500
Homepage URL
bee_jayz@hotmail.com
Sponsor or person
Institute
Aichi Children's Health and Medical Center
Institute
Department
Personal name
Funding Source
Organization
Aichi Children's Health and Medical Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Children's Health and Medical Center
Address
7-426, Morioka, Obu, Aichi 474-8710, Japan
Tel
+81-562-43-0500
bee_jayz@hotmail.com
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 | 08 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 25 | 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
| 2020 | Year | 08 | Month | 26 | Day |
Last modified on
| 2024 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047454
| 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 |
