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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046543
Receipt No. R000053103
Scientific Title A cross-sectional study on the immunological properties of the cow's milk protein hydrolysates and hydrolyzed formulas using blood samples from children with cow's milk allergy
Date of disclosure of the study information 2022/01/08
Last modified on 2022/01/05

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Basic information
Public title A cross-sectional study on the immunological properties of the cow's milk protein hydrolysates and hydrolyzed formulas using blood samples from children with cow's milk allergy
Acronym A cross-sectional study on the immunological properties of the cow's milk protein hydrolysates and hydrolyzed formulas using blood samples from children with cow's milk allergy
Scientific Title A cross-sectional study on the immunological properties of the cow's milk protein hydrolysates and hydrolyzed formulas using blood samples from children with cow's milk allergy
Scientific Title:Acronym A cross-sectional study on the immunological properties of the cow's milk protein hydrolysates and hydrolyzed formulas using blood samples from children with cow's milk allergy
Region
Japan

Condition
Condition Cow's milk allergy
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the immunological properties of the cow's milk protein hydrolysates and hydrolyzed formulas
Basic objectives2 Others
Basic objectives -Others The reactivities of IgE and basophils to food
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The reactivities of IgE and basophils to food
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
2 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria 1. Children from 2 to- 15 years old
2. Children with cow's milk allergy
3. Children having a history of immediate symptoms by milk components and cow's milk specific IgE level of 3.5 UA/ml or higher
4. Children who have a diet in which milk components are removed
5. Children who do not have any safety problem even if 7 ml of additional blood is collected at the time of normal blood collection
Key exclusion criteria 1. Children who took antihistamine agents within 3 days from the scheduled blood sampling date
2. Children who took the agents that affect the immune system such as steroids within 1 week from the scheduled blood sampling date
3. Children judged to be inappropriate as research subjects by the investigator
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Chisato
Middle name
Last name Inuo
Organization Kanagawa Chidren's Medical Center
Division name Department of Allergy
Zip code 232-8555
Address 2-138-4, Mutsukawa, Minami-Ku, Yokohama-City, Kanagawa, Japan
TEL 045-711-2351
Email cinuo@kcmc.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Matsubara
Organization Morinaga Milk Industry Co., Ltd.
Division name Health Care & Nutritional Science Institute, R&D Division
Zip code 252-8583
Address 1-83, 5-Chome, Higashihara, Zama-City, Kanagawa-Pref, Japan
TEL 046-252-3057
Homepage URL
Email ta-matsubara@morinagamilk.co.jp

Sponsor
Institute Kanagawa Chidren's Medical Center
Institute
Department

Funding Source
Organization Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kanagawa Chidren's Medical Center Institutional Review Board
Address 2-138-4, Mutsukawa, Minami-Ku, Yokohama-City, Kanagawa, Japan
Tel 045-711-2351
Email rinri.shinsei@kanagawa-pho.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 神奈川県立こども医療センター(神奈川県)

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 08 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
2021 Year 09 Month 27 Day
Date of IRB
2021 Year 10 Month 20 Day
Anticipated trial start date
2022 Year 01 Month 11 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information All patients who are scheduled to visit the facility from January 2022 to March in 2022 and meet the selection criteria will be recruited.

Management information
Registered date
2022 Year 01 Month 05 Day
Last modified on
2022 Year 01 Month 05 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053103

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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