UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042937 |
|---|---|
| Receipt number | R000049013 |
| Scientific Title | A study for immunostimulatory effects of intake of spore-forming lactic acid bacteria in adult men and women |
| Date of disclosure of the study information | 2021/01/08 |
| Last modified on | 2021/07/08 09:24:17 |
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Basic information
Public title
A study for immunostimulatory effects of intake of spore-forming lactic acid bacteria in adult men and women
Acronym
A study for immunostimulatory effects of intake of spore-forming lactic acid bacteria in adult men and women
Scientific Title
A study for immunostimulatory effects of intake of spore-forming lactic acid bacteria in adult men and women
Scientific Title:Acronym
A study for immunostimulatory effects of intake of spore-forming lactic acid bacteria in adult men and women
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the immunostimulatory effects of spore-forming lactic acid bacteria intake for 8 weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical condition questionnaire
s-IgA (Saliva)
IgA (Fecal)
Key secondary outcomes
POMS2
SF-36
Blood markers
(Inflammation,Immune,Stress)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food daily intake, for 8 weeks
Interventions/Control_2
Intake of placebo daily intake, for 8 weeks
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 working men and women between the ages of 20 and 64.
(2) Those with low saliva s-IgA during screening.
(3) Those who are prone to colds and flu.
(4) Those who suffered from upper respiratory tract infections in the winter of the last two years.
(5) Those who have received sufficient explanation of the purpose and content of this examination, have the ability to consent, and have volunteered to participate voluntarily after understanding well, who have agreed to participate in this examination in writing.
Key exclusion criteria
(1) Subjects having a disease or a history of serious diseases for which medication was required.
(2) Subjects who have chronic diseases and use drugs.
(3) Subjects who cannot stop the consumption of foods containing the components involved in test foods during the study period.
(4) Subjects who routinely use health food containing involvement ingredients.
(5) Subjects who get treatment affecting the test results.
(6) Subjects who cannot abstinence from 2 days before the inspection.
(7) Subjects having possibilities for emerging allergy related to the study.
(8) Subjects who have a history of digestive disorders and digestive surgery that affect digestion and absorption.
(9) Subjects who have experienced abnormal clinical test values or cardiopulmonary function and have been judged to have problems participating in the study.
(10) Subjects who have a history of drug dependence, alcohol dependence, or current medical history.
(11) Subjects who are prone to diarrhea when consuming dairy products.
(12) Night and day shift worker or manual laborer.
(13) Subjects who are or plan to perform dental care one month prior to pre-examination, currently, or during the study period.
(14) Subjects who have oral or dental problems with bleeding or develops the trouble.
(15) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination.
(16) Subjects who participated in other clinical studies and those who are willing to participate during the study period.
(17) Subjects who are planned to become pregnant or lactating.
(18) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(19) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Noriyoshi |
| Middle name | |
| Last name | Uchida |
Organization
Mitsubishi-Chemical Foods Corporation
Division name
Foods and Nutritions Science Div.
Zip code
100-8251
Address
1-1-1,Marunouchi,Chiyoda-ku,Tokyo, Japan
TEL
03-6748-7426
uchida.noriyoshi.mp@m-chemical.co.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Yamamichi |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
162-0822
Address
Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo, Japan
TEL
03-5657-4983
Homepage URL
yamamichi578@eps.co.jp
Sponsor or person
Institute
TTC Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi-Chemical 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
saito876@eps.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 08 | 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
| 2020 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 26 | 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 | 01 | Month | 07 | Day |
Last modified on
| 2021 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049013
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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