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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036718
Receipt No. R000041837
Scientific Title Effectiveness of Oral Immunotherapy for Food allergy
Date of disclosure of the study information 2019/05/13
Last modified on 2019/05/28

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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
Email 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
Email haneda0413@yahoo.co.jp

Sponsor
Institute Department of Pediatrics, Shimane University School of Medicine
Institute
Department

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 0853883057
Email sota@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 Open public recruiting
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
2023 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
2019 Year 05 Month 12 Day
Last modified on
2019 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041837

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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