Unique ID issued by UMIN | UMIN000035503 |
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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 |
The natural history of food protein-induced enterocolitis syndrome to hen's egg
The natural history of FPIES to hen's egg
The natural history of food protein-induced enterocolitis syndrome to hen's egg
The natural history of FPIES to hen's egg
Japan |
food protein-induced enterocolitis syndrome
Clinical immunology | Pediatrics |
Others
NO
To follow patients with food protein-induced enterocolitis syndrome (FPIES) to hen's egg to determine the natural history.
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.
The proportion of patients that have acquired tolerance to hen's egg at the age of 5 years.
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.
Observational
Not applicable |
Not applicable |
Male and Female
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
Patients with immediate-type hen's egg allergy.
Patients who are determined not suitable to participate in the study by the attending physician.
10
1st name | Makoto |
Middle name | |
Last name | Nishino |
National Hospital Organization Sagamihara National Hospital
Department of Pediatrics
252-0392
18-1, Minami-ku, Sakuradai, Sagamihara-city, Kanagawa, Japan, 252-0392
042-742-8311
kgarnettjp@yahoo.co.jp
1st name | Makoto |
Middle name | |
Last name | Nishino |
National Hospital Organization Sagamihara National Hospital
Department of Pediatrics
252-0392
18-1, Minami-ku, Sakuradai, Sagamihara-city, Kanagawa, Japan, 252-0392
042-742-8311
kgarnettjp@yahoo.co.jp
National Hospital Organization Sagamihara National Hospital
None
Other
National Hospital Organization Sagamihara Hospital Ethics Committee
18-1, Minami-ku, Sakuradai, Sagamihara-city, Kanagawa, Japan, 252-0392
042-742-8311
h-kushida@hosp.go.jp
NO
2019 | Year | 01 | Month | 17 | Day |
Unpublished
Enrolling by invitation
2018 | Year | 12 | Month | 28 | Day |
2018 | Year | 12 | Month | 21 | Day |
2019 | Year | 01 | Month | 17 | Day |
2023 | Year | 12 | Month | 31 | Day |
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.
2019 | Year | 01 | Month | 10 | Day |
2020 | Year | 01 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040321
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