UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034695 |
|---|---|
| Receipt number | 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 | 2020/05/01 09:39:25 |
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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
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
hiroko-nakai@house-wf.co.jp
Sponsor or person
Institute
House Wellness Foods Corporation Research and Development Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039551
| Research Plan | |
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| Registered date | File name |
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