UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028917 |
|---|---|
| Receipt number | 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 | 2023/03/06 14:27:05 |
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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
| Obstetrics 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 | Kazutoshi |
| Middle name | |
| Last name | Sayama |
Organization
Shizuoka University
Division name
College of Agriculture, Academic Institute
Zip code
4228529
Address
836 Ohya, Suruga-ku, Shizuoka 422-8529 Japan
TEL
81-54-238-4865
Sayama.kazutoshi@shizuoka.ac.jp
Public contact
Name of contact person
| 1st name | Kazutoshi |
| Middle name | |
| Last name | Sayama |
Organization
Shizuoka University
Division name
College of Agriculture, Academic Institute
Zip code
4228529
Address
836 Ohya, Suruga-ku, Shizuoka 422-8529 Japan
TEL
81-54-238-4865
Homepage URL
Sayama.kazutoshi@shizuoka.ac.jp
Sponsor or person
Institute
College of Agriculture, Academic Institute, Shizuoka University
Institute
Department
Personal name
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
Shizuoka University
Address
836, Ohya, Suruga-ku, Shizuoka-city
Tel
+81542384865
sayama.kazutoshi@shizuoka.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
| 2017 | Year | 08 | Month | 30 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0165037822003126?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0165037822003126?via%3Dihub
Number of participants that the trial has enrolled
53
Results
In this study, CCL25, a chemokine, was detected in human breast milk (HBM) for the first time. We then CCL25, CCL28, IL-7, and TSLP levels in the HBM were analyzed and compared their correlations and the levels between primiparous and multiparous women. As a result, it was showed that CCL25 and TSLP levels were significantly higher in colostrum than in mature milk. Moreover, CCL28 and IL-7 levels in colostrum showed a positive correlation.
Results date posted
| 2023 | Year | 03 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 02 | Month | 01 | Day |
Baseline Characteristics
A total of 53 women who completed full-term pregnancies and delivered vaginally at Shizuoka Saiseikai General Hospital were recruited.
Participant flow
We excluded women who fulfilled any of the following conditions: (1) those with diseases or a history of diseases affecting BM composition, (2) those who developed complications during delivery, and (3) those who delivered low-weight-birth infants (birth weight of <2.5 kg). All mothers provided written informed consent before participating in this study. Information on the mothers was obtained from them during hospitalization.
Adverse events
None
Outcome measures
CCL25, CCL28, IL-7 and TSLP in breast milk from subjects were measured by ELISA.
From the results of each measurement obtained, the contents in colostrum and regular milk and from Primiparous and Multiparous women were compared, and the correlation between the respective contents was analyzed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
We are analyzing the concentration of cytokines and chemokines in human breast milk, correlation between them and the individual difference between each mothers.
Management information
Registered date
| 2017 | Year | 08 | Month | 30 | Day |
Last modified on
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033088
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