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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036059
Receipt No. 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 2019/03/01

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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
Email 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
Email h-fuku@beanstalksnow.co.jp

Sponsor
Institute Bean Stalk snow Co., Ltd.
Research and Development Department
Institute
Department

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
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
2019 Year 03 Month 01 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 No longer recruiting
Date of protocol fixation
2013 Year 04 Month 19 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 17 Day
Last follow-up date
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
2019 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041053

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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