UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000035503
Receipt number 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 2020/01/11 10:39:35

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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 Makoto
Middle name
Last name Nishino

Organization

National Hospital Organization Sagamihara National Hospital

Division name

Department of Pediatrics

Zip code

252-0392

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 Makoto
Middle name
Last name Nishino

Organization

National Hospital Organization Sagamihara National Hospital

Division name

Department of Pediatrics

Zip code

252-0392

Address

18-1, Minami-ku, Sakuradai, Sagamihara-city, Kanagawa, Japan, 252-0392

TEL

042-742-8311

Homepage URL


Email

kgarnettjp@yahoo.co.jp


Sponsor or person

Institute

National Hospital Organization Sagamihara National Hospital

Institute

Department

Personal name



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

National Hospital Organization Sagamihara Hospital Ethics Committee

Address

18-1, Minami-ku, Sakuradai, Sagamihara-city, Kanagawa, Japan, 252-0392

Tel

042-742-8311

Email

h-kushida@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

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

2018 Year 12 Month 21 Day

Anticipated trial start date

2019 Year 01 Month 17 Day

Last follow-up date

2023 Year 12 Month 31 Day

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

2020 Year 01 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_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