UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043374
Receipt No. R000049523
Scientific Title A study for safety evaluation of excessive intake of Lactic acid bacterium-powder
Date of disclosure of the study information 2021/02/21
Last modified on 2021/02/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A study for safety evaluation of excessive intake of Lactic acid bacterium-powder
Acronym Safety evaluation of excessive intake of Lactic acid bacterium-powder
Scientific Title A study for safety evaluation of excessive intake of Lactic acid bacterium-powder
Scientific Title:Acronym Safety evaluation of excessive intake of Lactic acid bacterium-powder
Region
Japan

Condition
Condition None
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety of the excessive intake of Lactic acid bacterium-powder
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse event and side effect
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 Prevention
Type of intervention
Food
Interventions/Control_1 Intake of Lactic acid bacterium-powder 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)Subjects aged more than 20 years, less than 65 years.
2)Subjects who received an enough explanation of the test objectives and detail, who have consent ability, who are willing to participate with well understandings and who have signed the informed consent document.
Key exclusion criteria 1)Subjects who have a history of serious illness.
2)Subjects who are under treatment with medication for lifestyle-related disease (diabetes, hypertension, dyslipidemia).
3)Subjects who have digestive tract diseases that affect digestion and absorption, and have had a history of gastrointestinal surgery (excluding appendicitis).
4)Subjects who have a medical history of serious allergy to medicine, food and pollen.
5)Subjects who are pregnant or under lactation, or who is expected to be pregnant during the study.
6)Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
7)Subjects who are planning to participate in other clinical studies.
8)Subjects who are judged unsuitable for participating in this study by the principal investigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Masahiko
Middle name
Last name Tokushima
Organization Maebashi North Hospital
Division name Director
Zip code 371-0054
Address 692 Shimohosoi-machi,Maebashi-shi,Gumma
TEL 027-235-3333
Email sagawa@mc-connect.co.jp

Public contact
Name of contact person
1st name Eiji
Middle name
Last name Yoshikawa
Organization KSO Corporation
Division name Sales department
Zip code 105-0023
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

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical Committee of Kobuna Orthopedics Clinic
Address 5-656-17 Joto-machi, Maebashi-shi, Gumma
Tel 027-212-5608
Email sagawa@mc-connect.co.jp

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 医療法人 前橋北病院(群馬県)/ Maebashi North Hospital (Gunma)

Other administrative information
Date of disclosure of the study information
2021 Year 02 Month 21 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 Preinitiation
Date of protocol fixation
2021 Year 02 Month 12 Day
Date of IRB
2021 Year 02 Month 18 Day
Anticipated trial start date
2021 Year 02 Month 22 Day
Last follow-up date
2021 Year 04 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 02 Month 19 Day
Last modified on
2021 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049523

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.