UMIN-CTR Clinical Trial

Public title

Effects of fermented milk containing Bifidobacterium on improvements of gastrointestinal symptoms 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 on improvements of gastrointestinal symptoms 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

NO

Narrative objectives1

To evaluate the efficacy of intake of fermented milk containing Bifidobacterium for 4 weeks in healthy adults.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Gastrointestinal symptoms at 4 weeks after ingestion of test sample

Key secondary outcomes

Psychological symptoms, Breath test, Salivary stress marker, QOL at 4 weeks after ingestion of test sample

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

Fermented milk containing Bifidobacterium intake

Interventions/Control_2

Fermented milk not containing Bifidobacterium intake

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 64 years old.
2) 8 and over for modified FSSG score.
3) Subjects who understand details of the study and provides informed consent by documents.

Key exclusion criteria

1) Helicobacter pylori infection
2) Subjects who regularly use gastrointestinal drugs.
3) Functional Dyspepsia
4) Subjects who can't stop the ingestion of probiotics, prebiotics, foods containing lactic acid bacteria, bifidobacteria and other healthy foods which may affect gastrointestinal symptoms.
5) Subjects who have food allergy.
6) Subjects who have severe complication or serious diseases requiring an urgent treatment.
7) Subjects who have medical history of diseases or surgeries which affect digestion, absorption and defecation.
8) Subjects who are judged as unsuitable for the study by the blood test results of screening test.
9) Subjects who are planning to become pregnant during the study or are pregnant or lactating.
10) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
11) Subjects who are planning to participate or already participating in other clinical studies.
12) Subjects who are judged as unsuitable for the study by the investigator for other reasons.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Yoshitaka Iwama

Organization

Nihonbashi Cardiology Clinic

Division name

Director

Zip code

Address

Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo

TEL

03-5641-4133

Email

yiwama@well-sleep.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

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

2016

Year

10

Month

31

Day

URL releasing protocol

Publication of results

Published

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

2016

Year

10

Month

07

Day

Date of IRB

Anticipated trial start date

2016

Year

11

Month

05

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

10

Month

31

Day

Last modified on

2018

Year

06

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028363