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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031782
Receipt No. R000035927
Scientific Title Efficacy of yogurt to intestinal flora in Japanese healthy adults; a single arm, interventional study
Date of disclosure of the study information 2018/03/20
Last modified on 2019/04/16

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Basic information
Public title Efficacy of yogurt to intestinal flora in Japanese healthy adults; a single arm, interventional study
Acronym Efficacy of yogurt to intestinal flora in Japanese healthy adults
Scientific Title Efficacy of yogurt to intestinal flora in Japanese healthy adults; a single arm, interventional study
Scientific Title:Acronym Efficacy of yogurt to intestinal flora in Japanese healthy adults
Region
Japan

Condition
Condition healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of yogurt on the intestinal microbiome in healthy adults
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of intestinal microbiome before and after taking yogurt
Key secondary outcomes The change of bowel habits before and after taking yogurt

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 150 ml of yogurt (Yasuda Yogurt) is taken daily for 14 days. After 14-day wash out period, 300 ml of yogurt (Yasuda Yogurt) is taken daily for 14 days.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy subjects
Key exclusion criteria Subjects who meet any of the following conditions will be excluded.
1) Subjects who have a history of taking probiotics.
2) Subjects who have a history of a malignant disease.
3) Subjects who have lactose intolerance.
4) Subjects who have a history of a severe systemic disease.
5) Subjects who are judged unsuitable for this study by principal investigator.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshifumi Wakai
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Division of Digestive and General Surgery
Zip code
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata, Japan
TEL 025-227-2228
Email wakait@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yosuke Tajima
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Division of Digestive and General Surgery
Zip code
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata, Japan
TEL 025-227-2228
Homepage URL
Email y-tajima@med.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Yasuda Yogurt Co., Ltd
Bourbon Co., Ltd.


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
2018 Year 03 Month 20 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
2018 Year 02 Month 01 Day
Date of IRB
2018 Year 01 Month 16 Day
Anticipated trial start date
2018 Year 03 Month 25 Day
Last follow-up date
2022 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
2018 Year 03 Month 18 Day
Last modified on
2019 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035927

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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