UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017416 |
|---|---|
| Receipt number | R000019847 |
| Scientific Title | Slow Low-dose Oral Immunotherapy [SLOIT] for children with food allergies - non-randomized control trial - |
| Date of disclosure of the study information | 2015/05/04 |
| Last modified on | 2020/05/07 14:28:30 |
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Basic information
Public title
Slow Low-dose Oral Immunotherapy [SLOIT] for children with food allergies - non-randomized control trial -
Acronym
SLOIT for food allergies
Scientific Title
Slow Low-dose Oral Immunotherapy [SLOIT] for children with food allergies - non-randomized control trial -
Scientific Title:Acronym
SLOIT for food allergies
Region
| Japan |
Condition
Condition
food allergy
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Slow Low-dose Oral Immunotherapy (SLOIT)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the proportion of patients with negative results of oral food challenge for boiled egg white, cow's milk, udon noodle (0.2 - 0.5 - 1 - 2 - 5g or mL 30min interval)
Key secondary outcomes
Safety and continuity of the therapy.
The threshold dose of antigen and severity of allergic reaction provoked in OFCs.
The shift of laboratory data (e.g. specific IgE titer)
The frequency of rescue drug use and emergency department visit due to expected and unexpected allergic reaction in both groups.
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 allergen(boiled egg white, whole milk, udon noodle) every day according to the protocol.
Interventions/Control_2
elimination diet
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
| 2 | 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 during oral immunotherapy for other food antigen
patients with severe comorbidity
patients with uncontrollable asthma or atopic dermatitis
patients whose parents can not manage adrenalin autoinjector
patients who have developed anaphylaxis by tiny antigen (less than 1mL of milk or 1g of boiled egg, udon noodle) within one year before the oral food challenge.
patients whom the doctor asses ineligible
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | komei |
| Middle name | |
| Last name | Ito |
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
koumei_itoh@mx.achmc.pref.aichi.jp
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
Nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Childrens Health and Medical Center
Address
7-426, morioka, obu, Aichi
Tel
0562-43-0500
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
| 2015 | Year | 05 | Month | 04 | 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
| 2015 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 04 | Day |
Last modified on
| 2020 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019847
