UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024192 |
|---|---|
| Receipt number | R000027845 |
| Scientific Title | Step up Oral Food challenge Test (SOFT) for Egg allergies study- randomized control trial - |
| Date of disclosure of the study information | 2016/09/27 |
| Last modified on | 2019/01/10 17:01:59 |
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Basic information
Public title
Step up Oral Food challenge Test (SOFT) for Egg allergies study- randomized control trial -
Acronym
SOFT for Egg allergies
Scientific Title
Step up Oral Food challenge Test (SOFT) for Egg allergies study- randomized control trial -
Scientific Title:Acronym
SOFT for Egg 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 non-inferiority of elimination-releasing-methods by step up oral food challenge test compared with food instruction.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the proportion of patient who can ingest 20g of boiled egg white without symptom.
Key secondary outcomes
The amount of boiled egg white that the patients can ingested without symptom at the end of the protocol.
Safety of this protocol and compliance of the subjects.
The changes in value of laboratory data (e.g. specific IgE titer).
The changes in score of anxiety (the state-trait anxiety in ventory).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Step up oral food challenge test
Interventions/Control_2
dietary instruction
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
| 1 | years-old | <= |
Age-upper limit
| 4 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who avoid hen's egg containg-food for egg allergy or suspect of egg allergy.
Ovomucoid specific IgE titer is class 2 or below.
Patients who can eat 2g of boiled egg white in oral food challenge test without obvious allergic symptom.
Key exclusion criteria
patients with severe comorbidities
patients with uncontrollable asthma or atopic dermatitis
patients with anaphylaxic history by egg ingestion
patients who can ingest 2g or more of boiled egg white before oral food challenges
patients whom the doctor assess ineligible
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiro Sugiura |
Organization
Aichi Children's Health and Medical Center
Division name
Department of Allergy
Zip code
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 | |
| Middle name | |
| Last name | Katumasa Kitamura |
Organization
Aichi Children's Health and Medical Center
Division name
Department of Allergy
Zip code
Address
7-426, Morioka, Obu, Aichi 474-8710, Japan
TEL
0562430500
Homepage URL
kita0125@gmail.com
Sponsor or person
Institute
Aichi Children's Health and Medical Center
Institute
Department
Personal name
Funding Source
Organization
non
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
Address
Tel
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 | 09 | Month | 27 | 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 | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 27 | Day |
Last modified on
| 2019 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027845
