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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024347
Receipt No. R000028033
Scientific Title A clinical study for evaluating the safety of excessive intake of fermented milk drink. -Open study-
Date of disclosure of the study information 2016/10/10
Last modified on 2017/01/25

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Basic information
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
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes Hematologic test
Biochemistry test
Urinalysis
Blood pressure/pulse
Weight/body mass index
Medical interview
Adverse event
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

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 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

Research contact person
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

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, Japan
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)

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 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 10 Month 11 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 10 Day
Last modified on
2017 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028033

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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