UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024654
Receipt number R000028363
Scientific Title Effects of fermented milk containing Bifidobacterium on improvements of gastrointestinal symptoms in healthy adults; Randomized, double-blind, placebo-controlled, parallel-group study
Date of disclosure of the study information 2016/10/31
Last modified on 2018/06/21 10:07:16

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Basic information

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

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

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



Assessment

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


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

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



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 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


Research contact person

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


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

TEL

03-3452-7733

Homepage URL


Email

yoshikawa@kso.co.jp


Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name



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

2016 Year 10 Month 31 Day


Related information

URL releasing protocol


Publication of results

Published


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

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name