UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057119 |
|---|---|
| Receipt number | R000065279 |
| Scientific Title | Non-IgE-mediated Gastrointestinal Food Allergy: A Multicenter Prospective Observational Study to Identify Subgroups and Elucidate Clinical Course and Prognosis (the NICHOLAS cohort) |
| Date of disclosure of the study information | 2025/02/23 |
| Last modified on | 2025/02/23 14:49:13 |
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Basic information
Public title
Non-IgE-mediated Gastrointestinal Food Allergy: A Multicenter Prospective Observational Study to Identify Subgroups and Elucidate Clinical Course and Prognosis (the NICHOLAS cohort)
Acronym
The NICHOLAS cohort (National cohort to save lives of babies with gastrointestinal food allergy)
Scientific Title
Non-IgE-mediated Gastrointestinal Food Allergy: A Multicenter Prospective Observational Study to Identify Subgroups and Elucidate Clinical Course and Prognosis (the NICHOLAS cohort)
Scientific Title:Acronym
The NICHOLAS cohort (National cohort to save lives of babies with gastrointestinal food allergy)
Region
| Japan |
Condition
Condition
Non-IgE-mediated gastrointestinal food allergy
Classification by specialty
| Gastroenterology | Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to elucidate the detailed clinical characteristics of non-IgE-mediated gastrointestinal food allergy (non-IgE-GIFA) and to collect foundational data for the development of diagnostic criteria. In particular, we aim to identify distinct subgroups within the chronic form of non-IgE-GIFA.
Basic objectives2
Others
Basic objectives -Others
Additionally, we aim to estimate the remission timing for each subgroup, assess the prevalence of comorbid allergic disorders, and investigate whether differences in risk factors for disease onset exist between acute FPIES and its chronic form.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Data Collection Schedule:
Participants will be assessed at baseline (registration), at 6 months post-registration, at 1 year post-registration, and then annually until they reach 5 years of age (with the possibility of extension).
Primary Outcome Measures:
Parental Questionnaire: Assessment of symptoms, disease control status, treatment details, dietary intake, and the presence of any new allergic disorders.
Physician Case Report Form: Collection of clinical diagnosis (e.g., acute FPIES, chronic FPIES, FPE, FPIAP, or others), suspected trigger foods, anthropometric measurements, comorbid allergic disorders, blood test results, oral food challenge outcomes, and findings from endoscopic and pathological examinations.
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 | days-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Children who have visited one of the participating research medical institutions and, at the time of registration, were either diagnosed with or suspected of having a gastrointestinal food allergy by a physician.
2. The onset of the condition must have occurred before the child's second birthday (i.e., under 2 years of age).
3. At the time of registration, the child must be younger than 3 years of age (i.e., before their third birthday).
4. Informed consent has been obtained from the child's guardians.
Key exclusion criteria
1. Participants whose legal guardians are unable to understand Japanese.
2. Patients for whom the collaborating research physician has determined that it would be best not to participate in the study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Nomura |
Organization
National Center for Child Health and Development
Division name
Division of Eosinophilic Gastrointestinal Disorders
Zip code
1578535
Address
Okura 2-10-1, Setagaya-ku, Tokyo
TEL
81-3-3416-0181
nomura-i@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Ichiro |
| Middle name | |
| Last name | Nomura |
Organization
National Center for Child Health and Development
Division name
Division of Eosinophilic Gastrointestinal Disorders
Zip code
1578535
Address
Okura 2-10-1, Setagaya-ku, Tokyo
TEL
81-3-3416-0181
Homepage URL
nomura-i@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Ichiro Nomura
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Child Health and Development, Ethics Review Committee
Address
Okura 2-10-1, Setagaya-ku, Tokyo
Tel
81-3-3416-0181
rinri@ncchd.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
宮城こども病院（宮城県）
国立成育医療研究センター（東京都）
順天堂大学附属病院（東京都）
昭和大学病院（東京都）
東京慈恵医科大学附属第三病院（東京都）
東邦大学医療センター大森病院（東京都）
杏林大学病院（東京都）
東海大学附属病院（神奈川県）
あいち小児保健医療総合センター（愛知県）
国立病院機構三重病院（三重県）
大阪母子医療センター（大阪府）
広島大学附属病院（広島県）
広島赤十字原爆病院（広島県）
山口大学附属病院（山口県）
高知大学附属病院（高知県）
福岡市立こども病院 (福岡県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2033 | 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 multicenter prospective observational study designed to investigate the clinical course of non-IgE-mediated gastrointestinal food allergy (non-IgE-GIFA) and to identify distinct subgroups within its chronic form. Participants will be assessed at baseline (registration), 6 months post-registration, 1 year post-registration, and annually until the age of 5 (with a possibility of extension). Data collection includes parental questionnaires (symptoms, disease control, treatment details, food intake, presence of new allergic diseases) and physician case report forms (clinical diagnosis, suspected causative foods, anthropometric measurements, comorbid allergic diseases, laboratory test results, oral food challenge outcomes, and endoscopic/pathological findings). Written informed consent will be obtained from all guardians. The study has been approved by the relevant institutional ethics committees
Management information
Registered date
| 2025 | Year | 02 | Month | 23 | Day |
Last modified on
| 2025 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065279
