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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034822
Receipt No. R000039708
Official scientific title of the study Effect of Daily Intake of Heat-Killed Lactobacillus plantarum HOKKAIDO on Immunocompetence : A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Date of disclosure of the study information 2018/11/09
Last modified on 2018/11/08

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Basic information
Official scientific title of the study Effect of Daily Intake of Heat-Killed Lactobacillus plantarum HOKKAIDO on Immunocompetence : A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Title of the study (Brief title) Beneficial Effects of Heat-Killed Lactobacillus plantarum HOKKAIDO
on Immunocompetence
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To prove the effect of heat-killed Lactobacillus plantarum HOKKAIDO on immunocompetence associated with 8 week daily intake in a randomized, double-blind, placebo-controlled, parallel group study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes NK-cell activity at 4 and 8 weeks after beginning the intake of test food.
Key secondary outcomes IgA, IgG, IgM, neutrophils, lymphocytes, monocytes, eosinophils, basophils, neutrophil-lymphocyte ratio, salivary s-IgA VAS questionnaire assessed condition of gastrointestinal tract and fatigue, frequency of common cold symptoms.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Daily intake of 1 capsule containing heat-killed Lactobacillus plantarum HOKKAIDO for 8 weeks.
Interventions/Control_2 Daily intake of 1 capsule containing dextrin 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
30 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria 1.Subjects who agree to participate in this study with a written informed consent.
2.Subjects who show relatively low NK cell activity
Key exclusion criteria 1.Subjects with serious diseases and/or infections.
2.Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
3.Subjects with unusually high and/or low blood pressure and/or abnormal hematological data.
4.Subjects with severe anemia.
5.Pre- or post-menopausal women complaining of obvious physical changes.
6.Subjects who are at risk of having allergic reactions to drugs or foods.
7.Subjects who regularly intake products containing HOKKAIDO-strain.
8.Subjects who regularly take medicine, functional foods, and/or supplements which would affect immune function.
9.Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
10.Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study.
11.Pregnant or lactating women or women who expect to be pregnant during this study.
12.Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study.
13.Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size 70

Research contact person
Name of lead principal investigator Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4411
Email nishihira@do-johodai.ac.jp

Public contact
Name of contact person Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Health Information Science Research Center
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4430
Homepage URL
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

Funding Source
Organization Northern Advancement Center for Science & Technology
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 北海道情報大学 保健センター(北海道)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 09 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 09 Month 25 Day
Anticipated trial start date
2018 Year 11 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 08 Day
Last modified on
2018 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039708

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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