UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049072 |
|---|---|
| Receipt number | R000055906 |
| Scientific Title | Accidental ingestion of allergic food at eating-out and home replacement meal by children with food allergy |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2022/09/30 12:00:00 |
* 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
Accidental ingestion of allergic food at eating-out and home replacement meal by children with food allergy
Acronym
Accidental ingestion of allergic food at eating-out and home replacement meal by children with food allergy
Scientific Title
Accidental ingestion of allergic food at eating-out and home replacement meal by children with food allergy
Scientific Title:Acronym
Accidental ingestion of allergic food at eating-out and home replacement meal by children with food allergy
Region
| Japan |
Condition
Condition
Food Allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Conduct an investigation into the actual situation of accidental eating incidents at outside and inside meals for children with food allergies.
Basic objectives2
Others
Basic objectives -Others
Provide a basis for the prevention of accidents involving food allergy sufferers in food service and restaurant food
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of food allergy mishaps in food service and restaurant meals.
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
| 1 | months-old | < |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Physician-diagnosed food allergy patients.
Key exclusion criteria
none in particular
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Imai |
Organization
Showa University
Division name
School of Medicine, Department of Pediatrics
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
03-3784-8565
ta-imai@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Imai |
Organization
Showa University
Division name
School of Medicine, Department of Pediatrics
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
03-3784-8565
Homepage URL
ta-imai@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
none
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
School of Medicine
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
Tel
03-3784-8565
ta-imai@med.showa-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
| 2022 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1141
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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
There were 1141 valid responses, with 8 years as the median age of the participants. Moreover, 769 (67.4%) participants had a history of anaphylaxis, 622 (54.5%) experienced accidental ingestion, of which 485 (42.5%) and 348 (30.6%) occurred while eating out and at HRM, respectively. A total of 71 (14.6%) and 31 (8.9%) participants who had accidental ingestion while eating out and at HRM, respectively, required hospitalization. Age, milk allergy, and a history of anaphylaxis were risk factors significantly associated with accidental ingestion. The reasons for the accidental ingestions were personal and store-side error for a total of 438 cases of 356 cases, respectively.
Management information
Registered date
| 2022 | Year | 09 | Month | 30 | Day |
Last modified on
| 2022 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055906
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/09/30 | 外食中食DATA(最終解析).jmp |
