UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046543 |
|---|---|
| Receipt number | 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 | 2022/07/06 15:02:36 |
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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
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
ta-matsubara@morinagamilk.co.jp
Sponsor or person
Institute
Kanagawa Chidren's Medical Center
Institute
Department
Personal name
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
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
Completed
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 | 07 | Month | 06 | Day |
Link to view the page
Value
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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
