UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054017 |
|---|---|
| Receipt number | R000061669 |
| Scientific Title | Host and Environmental Factors Influencing the Development of Walnut and Cashew nut Allergy / Multicenter prospective cohort study |
| Date of disclosure of the study information | 2024/03/30 |
| Last modified on | 2024/04/02 15:13:10 |
* 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
Host and Environmental Factors Influencing the Development of Walnut and Cashew Allergy / Multicenter prospective cohort study
Acronym
Elucidation of Factors Influencing the Development of Nuts Allergy
Scientific Title
Host and Environmental Factors Influencing the Development of Walnut and Cashew nut Allergy / Multicenter prospective cohort study
Scientific Title:Acronym
Elucidation of Factors Influencing the Development of Walnut and Cashew nut Allergy
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore host and environmental factors that influence sensitization to walnuts or cashews in toddler through a prospective cohort study.
Basic objectives2
Others
Basic objectives -Others
To explore host and environmental factors that influence sensitization to walnuts or cashews in toddler through a prospective cohort study.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of positive sensitization to walnuts or cashews
Key secondary outcomes
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 | months-old | <= |
Age-upper limit
| 1 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with suspected food allergy seen at each study site who meet all of the following criteria
(1)Age: 3-11 months (at Visit 0)
(2)At least one specific IgE antibody titer to a food allergen that is greater than or equal to 0.35 kUA/L (as measured by ImmunoCAP method)
(3)Consent for this study was obtained from a surrogate (parents or legal guardians)
Key exclusion criteria
Patients with any of the following will not be included in this study
(1)Patients with severe atopic dermatitis (Eczema Area and Severity Index: EASI > 20 points)
(2)Children with a history of immediate symptoms of both walnut and cashew
(3)Patients with complications of diseases affecting the immune system (autoimmune diseases, immune complex diseases, immunodeficiency diseases, etc.)
(4)Patients with a history or complications of heart, liver, kidney, or blood (except iron deficiency anemia) disease
(5)Patients who are taking steroids on a regular basis
(6)Patients who are judged to be inappropriate by the principal investigator and physician in charge.
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | Sakura |
| Middle name | |
| Last name | Sato |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of Pediatrics and Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1, Sakuradai, Minami-ku, Sagamihara city, Kanagawa, Japan
TEL
042-742-8311
ssakura8010@foodallergy.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Kawai |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of Pediatrics and Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1, Sakuradai, Minami-ku, Sagamihara city, Kanagawa, Japan
TEL
042-742-8311
Homepage URL
akawai-ykh@umin.ac.jp
Sponsor or person
Institute
Department of Pediatrics and Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
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
National Hospital Organization
Address
2-5-23 Higashioka, Meguro-ku, Tokyo
Tel
03-5712-5050
700-kenkyu@mail.hosp.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
R5-NHO(Men)-01
Org. issuing International ID_1
National Hospital Organization
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
相模原病院（神奈川県）、三重病院（三重県）、名古屋医療センター（愛知県）、福山医療センター（広島県）、横浜医療センター（神奈川県）埼玉病院（埼玉県）別府医療センター（大分県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 30 | 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
| 2023 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood tests, basic participant information, dietary survey, clinical information on allergies, environmental antigen measurements, sample collection (skin and nasal discharge)
Management information
Registered date
| 2024 | Year | 03 | Month | 30 | Day |
Last modified on
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061669
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
