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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028917
Receipt No. R000033088
Scientific Title Analysis of cytokines and chemokines in human breast milk from parturient women
Date of disclosure of the study information 2017/08/30
Last modified on 2017/08/30

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Basic information
Public title Analysis of cytokines and chemokines in human breast milk from parturient women
Acronym Analysis of cytokines and chemokines in human breast milk
Scientific Title Analysis of cytokines and chemokines in human breast milk from parturient women
Scientific Title:Acronym Analysis of cytokines and chemokines in human breast milk
Region
Japan

Condition
Condition none
Classification by specialty
Obsterics and gynecology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Observational research
Basic objectives2 Others
Basic objectives -Others Componential analysis in human breast milk
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Concentration of cytokines and chemokines in human breast milk until 6 months after the parturition
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Parturient women which delivered normally and by cesarean section
Key exclusion criteria Parturient women which has galactacrasia
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutoshi Sayama
Organization Shizuoka University
Division name College of Agriculture, Academic Institute
Zip code
Address 836 Ohya, Suruga-ku, Shizuoka 422-8529 Japan
TEL 81-54-238-4865
Email Sayama.kazutoshi@shizuoka.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazutoshi Sayama
Organization Shizuoka University
Division name College of Agriculture, Academic Institute
Zip code
Address 836 Ohya, Suruga-ku, Shizuoka 422-8529 Japan
TEL 81-54-238-4865
Homepage URL
Email Sayama.kazutoshi@shizuoka.ac.jp

Sponsor
Institute College of Agriculture, Academic Institute, Shizuoka University
Institute
Department

Funding Source
Organization College of Agriculture, Academic Institute, Shizuoka University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Shizuoka Saisei-kai Hospital
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 08 Month 30 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2015 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 01 Day
Last follow-up date
2025 Year 12 Month 31 Day
Date of closure to data entry
2026 Year 03 Month 31 Day
Date trial data considered complete
2026 Year 03 Month 31 Day
Date analysis concluded
2026 Year 03 Month 31 Day

Other
Other related information We will analyze the concentration of cytokines and chemokines in human breast milk and the individual difference between each mothers.

Management information
Registered date
2017 Year 08 Month 30 Day
Last modified on
2017 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033088

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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