UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of fermented milk containing Bifidobacterium in healthy adults; Randomized, double-blind, placebo-controlled, parallel-group study
Title of the study (Brief title)	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	Satoru Suzuki
Organization	Shinagawa Season Terrace Health Care Clinic
Division name	Medical examination and treatment management family chief director
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	Eiji Yoshikawa
Organization	KSO Corporation
Division name	Sales department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000031262