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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034695
Receipt No. R000039551
Scientific Title A clinical study for evaluating the effects of long-term oral intake of lactic acid bacteria on intestinal flora in human subjects.
Date of disclosure of the study information 2018/10/31
Last modified on 2018/10/30

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Basic information
Public title A clinical study for evaluating the effects of long-term oral intake of lactic acid bacteria on intestinal flora in human subjects.
Acronym A clinical study for evaluating the effects of long-term oral intake of lactic acid bacteria on intestinal flora in human subjects.
Scientific Title A clinical study for evaluating the effects of long-term oral intake of lactic acid bacteria on intestinal flora in human subjects.
Scientific Title:Acronym A clinical study for evaluating the effects of long-term oral intake of lactic acid bacteria on intestinal flora in human subjects.
Region
Japan

Condition
Condition N/A
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the effects of continuous intake of lactic acid bacteria on intestinal flora, health conditions and immune functions in human subjects.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes At the 0th, 3th, 6th and 12th month of the intervention
(1) Intestinal flora analysis (stool tests)
(2) Immune functions (blood T cell number, PHA induced T cell proliferation)
Key secondary outcomes At the 0th, 3th, 6th and 12th month of the intervention
(1) Health conditions (inquiry consultation, physical inspection, questionnaire of dietary habits)
(2) Hematology, serum biochemistry, and urinalysis
(3) fecal IgA concentrations
(4) fecal short-chain fatty acid

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 Oral intake of lactic acid bacteria (one tablet per day for 12 months)
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Male and female subjects whose ages are over 20 years old
(2) Subjects judged as lower levels of bifidobacteria in their intestines by the investigator.
(3) Subjects who participate in this study with a written informed concent
Key exclusion criteria (1) Subjects who have consumed the lactic acid bacteria used in this clinical trial on a daily basis
(2) Subjects who are in pregnant or plan to get pregnant, or who are breastfeeding
(3) Patients with cancer who have taken radiotherapy, anti-cancer agents and/or hormone agents
(4) Patients with thyroid disease who have taken medicines such as Thyradin
(5) Patients with rheumatoid arthritis who have taken medicines such as Rheumatrex
(6) Subjects who are at risk of having allergic symptoms to test product of this clinical trial
(7) Subjects who are participating in the other clinical trial
(8) Subjects judged as unsuitable for this clinical trial by the investigator or sub investigator.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Hirose
Organization House Wellness Foods Corporation
Division name Research and Development Institute
Zip code
Address Imoji 3-20, Itami, Hyogo
TEL 072-778-1127
Email Hirose_Yoshitaka@house-wf.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Nakai
Organization House Wellness Foods Corporation
Division name Research and Development Institute
Zip code
Address Imoji 3-20, Itami, Hyogo
TEL 072-778-1127
Homepage URL
Email hiroko-nakai@house-wf.co.jp

Sponsor
Institute House Wellness Foods Corporation Research and Development Institute
Institute
Department

Funding Source
Organization House Wellness Foods Corporation
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
2018 Year 10 Month 31 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
2018 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 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
2018 Year 10 Month 30 Day
Last modified on
2018 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039551

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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