UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036718 |
|---|---|
| Receipt number | R000041837 |
| Scientific Title | Effectiveness of Oral Immunotherapy for Food allergy |
| Date of disclosure of the study information | 2019/05/13 |
| Last modified on | 2022/11/14 12:15:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effectiveness of Oral Immunotherapy for Food allergy
Acronym
Effectiveness of Oral Immunotherapy for Food allergy
Scientific Title
Effectiveness of Oral Immunotherapy for Food allergy
Scientific Title:Acronym
Effectiveness of Oral Immunotherapy for Food allergy
Region
| Japan |
Condition
Condition
food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy and safety of oral immunotherapy in food allergy patients.
Basic objectives2
Others
Basic objectives -Others
Identify the immunological background in the subjects.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Desensitization status rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake allergens systematically for 2 years. The intake will be increased systematically from below the threshold value set for each patient. The intake frequency is daily.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Food allergy diagnosed by oral food challenge test
2) The cause food is clear
3) It is difficult to expect natural remission to be acquired early
Key exclusion criteria
1) Contraindication of adrenaline administration.
2) Unstable bronchial asthma complicated.
3) Pregnant
4) Having a serious systemic disease (malignant tumor, autoimmune disease, immunodeficiency disease, severe heart disease, chronic infection etc.)
5) Use of systemic steroids and anti-cancer drugs
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Haneda |
Organization
Shimane University School of Medicine
Division name
Department of Pediatrics
Zip code
6938501
Address
89-1 Enya tyo, Izumo City, Shimane Prefecture
TEL
0853202219
haneda0413@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Haneda |
Organization
Shimane University School of Medicine
Division name
Department of Pediatrics
Zip code
6938501
Address
89-1 Enya tyo, Izumo City, Shimane Prefecture
TEL
0853202219
Homepage URL
haneda0413@yahoo.co.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 Enya tyo, Izumo City, Shimane Prefecture
Tel
0853202515
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
| 2019 | Year | 05 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 08 | 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
| 2019 | Year | 05 | Month | 12 | Day |
Last modified on
| 2022 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041837
