UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2018 Year 09 Month 21 Day
Date of IRB	2018 Year 10 Month 17 Day
Anticipated trial start date	2018 Year 11 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
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	2020 Year 05 Month 01 Day

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