UMIN-CTR Clinical Trial

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

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

YES

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

Primary outcomes

Gut microbiota

Key secondary outcomes

1) Fecal properties (water content, pH)
2) Fecal organic acids
3) Uremic toxins

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

KSO Corporation

Institute

Department

Personal name

Organization

Yakult Honsha Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

05

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

05

Month

09

Day

Last modified on

2018

Year

11

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031262