UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053814 |
|---|---|
| Receipt number | R000061407 |
| Scientific Title | Assessment of reproducibility after oral food challenge |
| Date of disclosure of the study information | 2024/03/11 |
| Last modified on | 2024/03/09 15:52:18 |
* 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
Assessment of reproducibility after oral food challenge
Acronym
Assessment of reproducibility after oral food challenge
Scientific Title
Assessment of reproducibility after oral food challenge
Scientific Title:Acronym
Assessment of reproducibility after oral food challenge
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the reproducibility of the same commercially available product at home (final diagnosis) in patients who passed the oral food challenge of the commercially available product (primary diagnosis).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of symptom occurrence at home.
Key secondary outcomes
(1) Percentage of positive results in the oral food challenge (primary diagnosis).
(2) Percentage of objective symptom occurrence at home.
(3) Percentage of occurrence of symptoms associated with each organ at home.
(4) Percentage of positive results at the final diagnosis.
(5) Percentage of patients who ingested the food at home.
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
Patients undergo an oral food challenge using commercially available products (primary diagnosis) and ingest the same commercially available products at home as they ingested in the oral food challenge (final diagnosis).
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
Children with a documented food allergy or suspected food allergy to hen's eggs, milk, wheat, peanuts, walnuts, cashews or almonds who consented to undergo an oral food challenge using commercially available products.
The target number of participants is approximately 100 for each food antigen, totaling approximately 800 participants.
Key exclusion criteria
Decision of ineligibility by a physician.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Yanagida |
Organization
NHO Sagamihara National Hospital
Division name
Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan
TEL
042-742-8311
yana@foodallergy.jp
Public contact
Name of contact person
| 1st name | Rui |
| Middle name | |
| Last name | Ozeki |
Organization
NHO Sagamihara National Hospital
Division name
Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan
TEL
042-742-8311
Homepage URL
rui.ozeki11@gmail.com
Sponsor or person
Institute
NHO Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
No
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
NHO Sagamihara National Hospital
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
Tel
042-742-8311
222-rinri@mail.hosp.go.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
| 2024 | Year | 03 | Month | 11 | 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 | 12 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 08 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 03 | Month | 09 | Day |
Last modified on
| 2024 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061407
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
