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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027287
Receipt No. R000031262
Scientific Title Effects of fermented milk containing Bifidobacterium in healthy adults; Randomized, double-blind, placebo-controlled, parallel-group study
Date of disclosure of the study information 2017/05/21
Last modified on 2018/11/20

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Basic information
Public title Effects of fermented milk containing Bifidobacterium in healthy adults; Randomized, double-blind, placebo-controlled, parallel-group study
Acronym Effects of fermented milk containing Bifidobacterium in healthy adults
Scientific Title Effects of fermented milk containing Bifidobacterium in healthy adults; Randomized, double-blind, placebo-controlled, parallel-group study
Scientific Title:Acronym Effects of fermented milk containing Bifidobacterium in healthy adults
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy of intake of fermented milk containing Bifidobacterium in healthy adults' gut microbiota
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gut microbiota
Key secondary outcomes 1) Fecal properties (water content, pH)
2) Fecal organic acids
3) Uremic toxins

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake fermented milk containing Bifidobacterium for 8 weeks
Interventions/Control_2 Intake placebo for 8 weeks
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
65 years-old >=
Gender Male and Female
Key inclusion criteria 1)Healthy men and women aged from 20 to 65 years old.
2)Subjects whose stool frequency is about 3 to 5 times a week.
3)Subjects who have low relative abundance of bifidobacterium in feces
4)Subjects who have low diversity of microbiota in feces.
5)Subjects who understand details of the study and provides informed consent by documents.
Key exclusion criteria 1)Subjects who regularly use intestinal drugs or laxatives.
2)Subjects who take drugs which affect gut microbiota such as antibiotics.
3)Subjects who have severe complication or serious diseases requiring an urgent treatment.
4)Subjects who have a chronic disease and use medicines constantly.
5)Subjects who have medical history of diseases or surgeries which affect digestion, absorption and defecation.
6)Subjects who repeat constipation and diarrhea such as irritable colitis.
7)Subjects who can't stop ingesting food containing lactic acid bacteria, bifidobacteria, oligosaccharide and viable bacteria.
8)Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
9)Subjects who are planning to become pregnant during the study or are pregnant or lactating.
10)Subjects who are planning to participate or already participating in other clinical studies.
11)Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoru Suzuki
Organization Shinagawa Season Terrace Health Care Clinic
Division name Medical examination and treatment management family chief director
Zip code
Address 1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace
TEL 03-3452-3381
Email satoru_suzuki@sempos.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Yoshikawa
Organization KSO Corporation
Division name Sales department
Zip code
Address 1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
TEL 03-3452-7733
Homepage URL
Email yoshikawa@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization Yakult Honsha Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
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
2017 Year 05 Month 21 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 Completed
Date of protocol fixation
2017 Year 01 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 21 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
2017 Year 05 Month 09 Day
Last modified on
2018 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031262

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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