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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035503
Receipt No. R000040321
Scientific Title The natural history of food protein-induced enterocolitis syndrome to hen's egg
Date of disclosure of the study information 2019/01/17
Last modified on 2019/01/31

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Basic information
Public title The natural history of food protein-induced enterocolitis syndrome to hen's egg
Acronym The natural history of FPIES to hen's egg
Scientific Title The natural history of food protein-induced enterocolitis syndrome to hen's egg
Scientific Title:Acronym The natural history of FPIES to hen's egg
Region
Japan

Condition
Condition food protein-induced enterocolitis syndrome
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To follow patients with food protein-induced enterocolitis syndrome (FPIES) to hen's egg to determine the natural history.
Basic objectives2 Others
Basic objectives -Others To determine the allergen which is responsible for the symptoms of hen's egg-induced FPIES by performing oral food challenges with egg yolk and egg white.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The proportion of patients that have acquired tolerance to hen's egg at the age of 5 years.
Key secondary outcomes The change in egg white, egg yolk, ovomucoid specific IgE levels. The change in wheal size of skin prick tests with egg white and egg yolk. The rate of atopic dermatitis, asthma, allergic rhinitis, and food allergy to foods other than hen's egg at the age of 5 years.

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

Not applicable
Gender Male and Female
Key inclusion criteria Patients included in the study will be either A) or B)
A) Patients who are diagnosed with hen's egg-induced FPIES by meeting the major criterion and 3 or more minor criteria.
B) Patients who are suspected of hen's egg-induced FPIES by meeting the major criterion but meet less than 3 minor criteria.

Major criterion:
Vomiting in the 1-4 hour period after ingestion of the suspected food and the absence of classic IgE-mediated allergic skin or respiratory symptoms.

Minor criteria:
1. A second (or more) episode of repetitive vomiting after eating the same suspected food.
2. Repetitive vomiting episode 1-4 hours after eating a different food.
3. Extreme lethargy with any suspected reaction
4. Marked pallor with any suspected reaction
5. Need for emergency department visit with any suspected reaction
6. Need for intravenous fluid support with any suspected reaction
7. Diarrhea within 24 hours
8. Hypotension
9. Hypothermia
Key exclusion criteria Patients with immediate-type hen's egg allergy.
Patients who are determined not suitable to participate in the study by the attending physician.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Nishino
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of Pediatrics
Zip code
Address 18-1, Minami-ku, Sakuradai, Sagamihara-city, Kanagawa, Japan, 252-0392
TEL 042-742-8311
Email kgarnettjp@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Nishino
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of Pediatrics
Zip code
Address 18-1, Minami-ku, Sakuradai, Sagamihara-city, Kanagawa, Japan, 252-0392
TEL 042-742-8311
Homepage URL
Email kgarnettjp@yahoo.co.jp

Sponsor
Institute National Hospital Organization Sagamihara National Hospital
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2019 Year 01 Month 17 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
2018 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients diagnosed with hen's egg-induced FPIES will undergo oral food challenges every 12-18 months until the age of 5 to determine whether they have acquired tolerance.

Management information
Registered date
2019 Year 01 Month 10 Day
Last modified on
2019 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040321

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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