UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020307 |
|---|---|
| Receipt number | R000023448 |
| Scientific Title | A study for evaluating the effects of oral intake of lactic acid bacteria on immune function. A randomized, double-blind, placebo- controlled trial. |
| Date of disclosure of the study information | 2015/12/24 |
| Last modified on | 2016/08/08 13:23:58 |
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Basic information
Public title
A study for evaluating the effects of oral intake of lactic acid bacteria on immune function. A randomized, double-blind, placebo- controlled trial.
Acronym
A study for evaluating the effects of oral intake of lactic acid bacteria on immune function.
Scientific Title
A study for evaluating the effects of oral intake of lactic acid bacteria on immune function. A randomized, double-blind, placebo- controlled trial.
Scientific Title:Acronym
A study for evaluating the effects of oral intake of lactic acid bacteria on immune function.
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of oral intake of lactic acid bacteria on immune functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of cytokines production and expression levels of anti-viral genes of peripheral blood mononuclear cells stimulated by viruses at 4 weeks after intervention.
Key secondary outcomes
Activities of dendritic cells in peripheral blood at 4 weeks after intervention. (Cell surface expression levels of dendritic cells makers.)
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
Lactic acid bacteria, 1 portion of food per day for 4 weeks.
Interventions/Control_2
Placebo (not containing lactic acid bacteria), 1 portion of food per day for 4 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)Males and females aged from 20 to less than 65 years old, when giving the informed consent.
2)Individuals who have low activities of immune cells in peripheral blood.
3)Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will.
Key exclusion criteria
1)Individuals who can't stop drinking for 2 days until the screening and each checkup.
2)Individuals who can't stop eating foods containing lactic acid bacteria and oligosaccharide during this study.
3)Individuals who can't stop eating foods which may activate immune functions.
4)Individuals who have tendency to get diarrhea by eating dairy product.
5)Individuals who have a history of irritable bowel syndrome and Crohn's disease.
6)Individuals who was vaccinated and who may receive it this year.
7)Individuals who have a medical history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder.
8)Individuals who have chronic diseases and use medicines continuously.
9)Individuals who have under treatment or a history of drug addiction and/or alcoholism.
10)Individuals who are judged as unsuitable for the study based on the results of blood test.
11)Individuals with excessive alcohol-drinking behaviors.
12)Individuals who have a medical history of diseases affecting digestion and absorption.
13)Individuals who have a medical history of hay fever.
14)Individuals having food allergy.
15)Individuals who are pregnant, breastfeeding, or planning to be pregnant in the near future.
16)Individuals who are participating or willing to participate in other clinical trials or in the last 3 months.
17)Individuals who and whose family work for a company manufacturing or selling healthy foods or functional foods.
18)Individuals who are judged unsuitable for this study by the investigator for other reasons.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhi Sugimura |
Organization
C'est la vie Shimbashi Clinic
Division name
Medical office
Zip code
Address
2-39-3 Nishishimbashi, Minato-ku, Tokyo
TEL
03-5408-8671
h-sugimura@shinkokai.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
Address
1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL
03-3452-7733
Homepage URL
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Kirin Company, Limited
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
医療法人社団進興会 セラヴィ新橋クリニック／Medical Corporation Shinkou Kai C'est la vie Shinbashi Clinic
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 24 | 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
| 2015 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 25 | 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
| 2015 | Year | 12 | Month | 22 | Day |
Last modified on
| 2016 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023448
