UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048007 |
|---|---|
| Receipt number | 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 14:59:12 |
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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
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
kyoko@yokohama-nishikage.clinic
Sponsor or person
Institute
Yokohama Nishikage Clinic: kids and allergies
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052813
