UMIN-CTR Clinical Trial

Public title

A clinical study for evaluating the safety of excessive intake of fermented milk drink. -Open study-

Acronym

A clinical study for evaluating the safety of excessive intake of fermented milk drink.

Scientific Title

A clinical study for evaluating the safety of excessive intake of fermented milk drink. -Open study-

Scientific Title:Acronym

A clinical study for evaluating the safety of excessive intake of fermented milk drink.

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the safety of excessive intake of fermented milk drink for 4 weeks in healthy adults.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Hematologic test
Biochemistry test
Urinalysis
Blood pressure/pulse
Weight/body mass index
Medical interview
Adverse event

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Consumption of fermented milk drink, 3-fold quantity of recommended daily intake, for 4 weeks.

Interventions/Control_2

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 20 to 64 years old.
2) Subjects who tend to be constipated (defecation frequency is 3-5 times per week) or have daily defecation.
3) Subjects who eat 3 meals regularly in one day.
4) Subjects who can stop drinking from 2 days before each inspection date.
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 have severe complication or serious diseases requiring an urgent treatment.
3) Subjects who have a chronic disease and use medicines constantly.
4) Subjects who have medical history of diseases or surgeries which affect digestion and absorption.
5) Subjects who repeat constipation and diarrhea such as irritable colitis.
6) Subjects who regularly use functional foods which help relieve constipation (including Food for Specified Health Uses, Foods with Function Claims)
7) Subjects who take drugs which affect digestion and absorption such as antibiotics at screening test.
8) Subjects who can't stop ingesting food containing lactic acid bacteria, bifidobacteria, oligosaccharide and viable bacteria, large amounts of sugar alcohol or functional foods (including Food for Specified Health Uses, Foods with Function Claims) which help relieve constipation.
9) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
10) Subjects who have tendency to get diarrhea by ingesting milk.
11) Subjects who have food allergy.
12) Subjects who are judged as unsuitable for the study by screening questionnaire.
13) Subjects who are judged as unsuitable for the study by the blood test results of screening test.
14) Subjects who are planning to become pregnant during the study or are pregnant or lactating.
15) Subjects who are planning to participate or already participating in other clinical studies.
16) Subjects who are judged as unsuitable for the study by the investigator for other reasons.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Yasuo Kobuna

Organization

Kobuna Orthopedics Clinic

Division name

Director

Zip code

Address

311-2 Gokan-machi, Maebashi-shi, Gumma, Japan

TEL

027-261-7600

Email

info@kobunaseikei.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, Japan

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

10

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

2016

Year

10

Month

07

Day

Date of IRB

Anticipated trial start date

2016

Year

10

Month

11

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

10

Day

Last modified on

2017

Year

01

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028033