UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036059 |
|---|---|
| Receipt number | R000041053 |
| Scientific Title | A study for probiotics supplementation effect on lactating women. |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2022/09/02 10:49:07 |
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Basic information
Public title
A study for probiotics supplementation effect on lactating women.
Acronym
A study for probiotics supplementation effect on lactating women.
Scientific Title
A study for probiotics supplementation effect on lactating women.
Scientific Title:Acronym
A study for probiotics supplementation effect on lactating women.
Region
| Japan |
Condition
Condition
Lactating women with allergies
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the tolerance and effects of probiotics(Lactobacillus casei LC5 strain 5 billion cfu, Bifidobacterium longum BG7 strain 5 billion cfu, and Bacillus coagulans SANK70258 strain 0.2 billion cfu) supplementation on TGF-b and IgA levels in human milk of lactating women with allergies in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Health condition monitoring based on self-reported diary throughout the study periods.
Key secondary outcomes
Adherence of intervention.
TGF-b and IgA in human milk.
Other components in human milk.
Lifestyle-associated factors.
Dietary patterns based on food frequency questionnaire.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
3 tablets once a day after breakfast for 2 months (1-3 months postpartum).
Interventions/Control_2
No-intervention control in 2 months (1-3 months postpartum).
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1) Lactating
2) 30 days to 59 days postpartum
3) A history of allergy at recruitment. The maternal allergy history was determined based on a reported clinical history of atopic eczema, asthma, or allergic rhinitis.
Key exclusion criteria
1) Clinical evidence of chronic illness or gastrointestinal disorder.
2) Routine use of any other dietary supplements containing probiotics and fiber.
3) Smoking at recruitment.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taku Nakano |
Organization
Bean Stalk snow Co., Ltd.
Division name
Research and Development Department
Zip code
Address
1-1-2 Minamidai, Kawagoe, Saitama, Japan
TEL
049-242-8138
nakano@meg-snow.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Fukudome |
Organization
Bean Stalk snow Co., Ltd.
Division name
Research and Development Department
Zip code
Address
1-1-2 Minamidai, Kawagoe, Saitama, Japan
TEL
049-242-8138
Homepage URL
h-fuku@beanstalksnow.co.jp
Sponsor or person
Institute
Bean Stalk snow Co., Ltd.
Research and Development Department
Institute
Department
Personal name
Funding Source
Organization
Bean Stalk snow Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.frontiersin.org/articles/10.3389/fnut.2019.00128/full
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/articles/10.3389/fnut.2019.00128/full
Number of participants that the trial has enrolled
60
Results
No adverse effects were observed in the probiotic group, according to the self-recorded diary during the study period. Milk IgA decreased with increasing postpartum months in both groups. In contrast, TGF-b1 and b2 were not affected by lactation periods, and showed different patterns over time between the two groups. TGF-b1, TGF-b1, and IgA levels were significantly correlated at baseline. However, the correlation between TGF-b1 and IgA became non-significant by the end of the intervention.
Results date posted
| 2022 | Year | 09 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 09 | Month | 03 | Day |
Baseline Characteristics
https://www.frontiersin.org/articles/10.3389/fnut.2019.00128/full
DOI: 10.3389/fnut.2019.00128
Participant flow
https://www.frontiersin.org/articles/10.3389/fnut.2019.00128/full
DOI: 10.3389/fnut.2019.00128
Adverse events
https://www.frontiersin.org/articles/10.3389/fnut.2019.00128/full
DOI: 10.3389/fnut.2019.00128
Outcome measures
https://www.frontiersin.org/articles/10.3389/fnut.2019.00128/full
DOI: 10.3389/fnut.2019.00128
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 01 | Day |
Last modified on
| 2022 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041053
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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