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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000048007
Receipt No. R000052813
Scientific Title efficacy and safety of Ultra low dose oral immunotherapy for severe nut allergy; open label multi centered observational study
Date of disclosure of the study information 2022/06/15
Last modified on 2022/06/09

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Basic information
Public title efficacy and safety of allergen extract dropping therapy for severe peanut and nut (walnut) allergy
Acronym AEDIT for severe nut allergy
Scientific Title efficacy and safety of Ultra low dose oral immunotherapy for severe nut allergy; open label multi centered observational study
Scientific Title:Acronym ULDOIT for severe peanut and nut(walnut)
allergy
Region
Japan

Condition
Condition food allergy
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluating the tolerance induction ability of ultra low dose oral immunotherapy using individually adjusted safe-proven diluted allergen extracts for severe peanut and nut (walnut) allergy subjects whose only treatment has been an elimination diet because of severe adverse reactions to oral food challenges of the offending foods in mg units.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes the rate of the subjects who could have been administered a usual oral immunotherapy using peanut or nut(walnut) powder in mg unit during the test period.
Key secondary outcomes 1.oral challenge threshold changes of serially diluted allergen extracts; verified every month till 24 months after the research start.
2. oral challenge threshold changes of antigen powders in mg units.(every month)
3.threshold changes of skin prick tests of serially diluted allergen extracts.(every year)
4. changes of wheel size of skin prick tests of diluted allergen extracts.(
every year)
5. antigen specific IgE level change (every year)
6.Basophil Activation Test results on several diluted allergen extracts(before and after the study)
7.the rate of subjects who could intake allergen nut containing foods.
8.safety evaluation (the rate of adverse reactions at challenge phases in a clinic setting and maintenance phases at home)


Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
3 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria the subjects whose severe adverse reactions to peanut or nut(walnut)- intake have been diagnosed by physicians, and whose prick tests or antigen and its component specific IgE levels have shown positive results.
The above subjects are also required to fulfill the conditions mentioned below.
1.who have been on strict elimination diet and incapable of starting oral immunotherapy because of severe adverse reactions to oral food challenge tests or accidental ingestions in the past.
2.who have not been able to increase the intake-dose because of adverse reactions during oral immunotherapy
Key exclusion criteria the subjects who have the conditions bellow
1.poorly controlled atopic dermatitis
2.poorly controlled asthma
3.immunodeficiency
4.taking beta blockers
5. pregnancy
6. taking medications for psychiatric disorders except child developmental disorders
7.malignant diseases
Target sample size 20

Research contact person
Name of lead principal investigator
1st name kyoko
Middle name S
Last name Nishikage
Organization Yokohama Nishikage Clinic: kids and allergies
Division name medical department
Zip code 2210834
Address 15-1 Daimachi Kanagawa-ku, Yokohama city, Japan
TEL 0453235115
Email kyoko@yokohama-nishikage.clinic

Public contact
Name of contact person
1st name kyoko
Middle name S
Last name Nishikage
Organization Yokohama Nishikage Clinic: kids and allergies
Division name medical department
Zip code 2210834
Address 15-1 Daimachi Kanagawa-ku, Yokohama city, Japan
TEL 0453235115
Homepage URL
Email kyoko@yokohama-nishikage.clinic

Sponsor
Institute Yokohama Nishikage Clinic: kids and allergies
Institute
Department

Funding Source
Organization self funding
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 Hitachi Omika Hospital Institutional Review Board
Address Mitsui Tower Clinic 2-1-1 Muromachi Nihonbashi chuo-ku, Tokyo
Tel 0335109955
Email minatocl@ruby.ocn.ne.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 06 Month 15 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 Enrolling by invitation
Date of protocol fixation
2019 Year 03 Month 01 Day
Date of IRB
2021 Year 05 Month 08 Day
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
2026 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information design: multi centered open observational study without control groups
recruitment period: from 2019 March 1st to 2024 February
recruitment method: all the patients who visited our facilities and met the selection criteria
measurement item: specific IgE level, skin prick test, basophil activated test, oral challenge threshold of allergen extract dilutions, oral challenge threshold of nuts (peanut or walnut)contained foods or nuts' powders


Management information
Registered date
2022 Year 06 Month 09 Day
Last modified on
2022 Year 06 Month 09 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052813

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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