UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041060
Receipt number R000046718
Scientific Title Phenotyping study of fish allergy
Date of disclosure of the study information 2020/07/13
Last modified on 2020/07/10 11:54:31

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Basic information

Public title

Phenotyping study of fish allergy

Acronym

Phenotyping study of fish allergy

Scientific Title

Phenotyping study of fish allergy

Scientific Title:Acronym

Phenotyping study of fish allergy

Region

Japan


Condition

Condition

Food allergy

Classification by specialty

Clinical immunology Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We classify patients with fish allergy into phenotypes according to the presence or absence of sensitization to parvalbumin and collagen, and examine whether differ the species of fish and the cooking method, that can be ingested without allergic symptom, depending on the phenotype.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Difference in the recipe of the yellowtail (raw, grilled fish, boiled fish) that induces allergic symptoms among the 4 phenotypes.

Key secondary outcomes

Differences in ingestible fish species, recipes, and positive rates of skin prick test among the four phenotypes.


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


Not applicable

Age-upper limit

15 years-old >=

Gender

Male and Female

Key inclusion criteria

Intended for those who meet all of the following criteria
・Male and female under 15 years old
・Two or more episodes of immediate allergic reaction or gastrointestinal symptom, which including FPIES, after ingestion of fish
・Persons who have written consent to participate in this study by their legal guardians

Key exclusion criteria

Patients who meet any of the following will not be included in this study:
・If we suspect ananisakis allergy, histamine poisoning, or psychogenicity
・If the subject has other serious complications and is not suitable for this study

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Osamu
Middle name
Last name Natsume

Organization

Hamamatsu University School of Medicine

Division name

Pediatric

Zip code

431-3192

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture

TEL

053-435-2312

Email

allergy@hama-med.ac.jp


Public contact

Name of contact person

1st name Osamu
Middle name
Last name Natsume

Organization

Hamamatsu University School of Medicine

Division name

Pediatric

Zip code

431-3192

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture

TEL

053-435-2312

Homepage URL


Email

allergy@hama-med.ac.jp


Sponsor or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Hamamatsu University School of Medicine

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

Hamamatsu University School of Medicine

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture

Tel

053-435-2312

Email

allergy@hama-med.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

2020 Year 07 Month 13 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

2020 Year 01 Month 01 Day

Date of IRB

2020 Year 02 Month 28 Day

Anticipated trial start date

2020 Year 07 Month 07 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is a multi-institutional cross-sectional study and will be conducted between the 2020 and March 2023.
Blood test (component-specific IgE test) and a skin prick test will be conducted on children diagnosed with fish allergies.
On the day of registration, additional serum for blood tests will be collected and a questionnaire will be distributed. At a later date, a skin prick test will be conducted and questionnaires will be collected.
The result of blood tests (parvalbumin sIgE and collagen sIgE), positive or negative are used to classify phenotypes for fish allergies.
We examine the differences in the types of fish and the cooking methods that can be ingested without allergic symptom between the four phenotype of fish allergy.


Management information

Registered date

2020 Year 07 Month 10 Day

Last modified on

2020 Year 07 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046718


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name