UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049359 |
|---|---|
| Receipt number | R000056181 |
| Scientific Title | Safety and Efficacy of slow low-dose oral immunotherapy Shimane version for patients with positive low-dose oral food challenge |
| Date of disclosure of the study information | 2022/10/28 |
| Last modified on | 2022/11/02 11:10:38 |
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Basic information
Public title
Safety and Efficacy of slow low-dose oral immunotherapy Shimane version for patients with positive low-dose oral food challenge
Acronym
Shimane-SLOIT 2022
Scientific Title
Safety and Efficacy of slow low-dose oral immunotherapy Shimane version for patients with positive low-dose oral food challenge
Scientific Title:Acronym
Shimane-SLOIT 2022
Region
| Japan |
Condition
Condition
food allergy
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Shimane-SLOIT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The result of oral food challenges after one-year of Shimane-SLOIT
Key secondary outcomes
safety of Shimane-SLOIT
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Slow low dose oral immunotherapy
(ingesting hen's egg, cow milk and wheat protein everyday with increasing the dose at home whenever they could for every 30 consecutive intakes without obviouslious allergic symptoms)
Interventions/Control_2
complete avoidance of antigen
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
| 16 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed with FA of either egg, milk, or wheat.
2) Less than 16 years of age at the time of consent.
3) Weighs 15 kg or more and is able to possess epinephrine autoinjector.
4) Positive oral food challenge with less than 3.5 g of boiled egg white or udon noodles or less than 3.5 mL of cow's milk.
5) Written consent to participate in the study has been obtained from the parents.
Key exclusion criteria
1) severe anaphylaxis induced by oral food challenge
2) uncontrolled bronchial asthma or atopic dermatitis
3) Has malignancy, autoimmune disease, immunodeficiency, severe cardiac disease, or chronic infectious disease
4) Consecutive use of systemic corticosteroids or anticancer agents
5) Undergoing other immunotherapy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Seiya |
| Middle name | |
| Last name | Masukane |
Organization
Shimane University School of Medicine
Division name
Department of Pediatrics
Zip code
693-8501
Address
89-1, Enyacho, Izumoshi, Shimane
TEL
0853-20-2220
masukane@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Seiya |
| Middle name | |
| Last name | Masukane |
Organization
Shimane University School of Medicine
Division name
Department of Pediatrics
Zip code
693-8501
Address
89-1, Enyacho, Izumoshi, Shimane
TEL
0853-20-2220
Homepage URL
masukane@med.shimane-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Shimane University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Pediatrics, Shimane University School of Medicine
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
Shimane University School of Medicine Clinical Research Center Clinical Research Support Division
Address
89-1, Enyacho, Izumoshi, Shimane
Tel
0853-20-2259
kenkyu@med.shimane-u.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
| 2022 | Year | 10 | Month | 28 | 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
| 2022 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2028 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 28 | Day |
Last modified on
| 2022 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056181
