UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039839 |
|---|---|
| Receipt number | R000045437 |
| Scientific Title | Investigation of effect of continuous intake of artificial milk on prevention of food allergy |
| Date of disclosure of the study information | 2020/03/27 |
| Last modified on | 2020/03/17 08:05:38 |
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Basic information
Public title
Investigation of effect of continuous intake of artificial milk on prevention of food allergy
Acronym
Investigation of effect of continuous intake of artificial milk on prevention of food allergy
Scientific Title
Investigation of effect of continuous intake of artificial milk on prevention of food allergy
Scientific Title:Acronym
Investigation of effect of continuous intake of artificial milk on prevention of food allergy
Region
| Japan |
Condition
Condition
Food Allergy
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of effect of artificial milk on allergy prevention
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of milk allergy at 12 month after birth
Key secondary outcomes
specific IgE of milk and casein at 12 month after birth
Frequency of athma, rhinitis, eczema ,food allergy at 24 month after birth
specific IgE of mite at 12 month after birth
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
| 7 | days-old | >= |
Gender
Male and Female
Key inclusion criteria
Neonate within 7days after birth
1, Gestation 37 weeks or more
2, Birth weight 2500g or more
3,babys who can go home within 7 days after birth
Key exclusion criteria
1, congenital anomaly
2, Have difficulty breastfeeding with antiepileptic and antipsychotic drugs
3, Those who do not give their consent to participate in this study
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Hidaka |
Organization
University of Tsukuba Hospital
Division name
Pediatrics
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, JAPAN
TEL
029-853-3900
hitaka-tuk@umin.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Hayashi |
Organization
Tsukuba Medical Center Hospital
Division name
Pediatrics
Zip code
305-8558
Address
1-3-1 Amakubo, Tsukuba, Ibaraki, JAPAN
TEL
029-851-3511
Homepage URL
hayashi_daisuke@tmch.or.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Depertment of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
J Milk
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba Clinical Reserchi and Development Organization
Address
1-3-1 Amakubo, Tsukuba, Ibaraki, JAPAN
Tel
029-853-3914
rinshokenkyu@un.tsukuba.ac.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
| 2020 | Year | 03 | Month | 27 | 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
| 2019 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational birth cohort study
Observe relationship between intake of artificial milk and milk allergy.
Management information
Registered date
| 2020 | Year | 03 | Month | 17 | Day |
Last modified on
| 2020 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045437
| 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 |
