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Recruitment status Completed
Unique ID issued by UMIN UMIN000014138
Receipt No. R000016080
Scientific Title Assessment of immunocompetence by the intake of Lactobacillus plantarum HOKKAIDO contained yogurt
Date of disclosure of the study information 2014/06/02
Last modified on 2015/10/06

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Basic information
Public title Assessment of immunocompetence by the intake of Lactobacillus plantarum HOKKAIDO contained yogurt
Acronym Effects of Lactobacillus plantarum HOKKAIDO on immune functions
Scientific Title Assessment of immunocompetence by the intake of Lactobacillus plantarum HOKKAIDO contained yogurt
Scientific Title:Acronym Effects of Lactobacillus plantarum HOKKAIDO on immune functions
Region
Japan

Condition
Condition Low immune system
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to evaluate effects of fermented milk (yogurt) containing Lactobacillus plantarum HOKKAIDO for activation of immune functions by double-blind, placebo-controlled test.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes NK cell activity
Key secondary outcomes Five fraction of leukocyte, IgG, IgE, IgM, IL-1, IL-4, IL-6, IL-8, IL-10, IL-12, T-Cho, LDL-Cho, HDL-Cho, TG, FBG, HbA1c, 25-OHD, MIF

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake 90 g of yogurt containing Lactobacillus plantarum HOKKAIDO daily for 8 weeks.
Interventions/Control_2 Intake 90 g of yogurt daily for 8 weeks.
Interventions/Control_3 Intake 90 g of yogurt-like non-fermented products daily for 8 weeks.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
30 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1.Subjects who show relatively low NK cell
activity
2.Subjects who agree to participate in the
current study with written informed
consent
Key exclusion criteria 1. Subjects who are under medication for chronic ailments.
2. Subjects with serious diseases and/or infections.
3. Subjects with clinical history of major gastrointestinal surgery.
4. Subjects with frequent complaints and/or symptoms relevant to post-menopausal events.
5. Subjects with unusually high and/or low blood pressure, or with abnormal hematological data.
6. Subjects with serious anemia.
7. Subjects with a history of allergy to medicine and/or food, especially dairy products.
8. Subjects regularly on supplementation which would affect the immune system.
9. Subjects who often intake Hokkaido-strain containing products
10. Heavy smokers and alcohol addicts, or subjects with extremely irregular lifestyle.
11.Subjects who donated 400ml whole blood within 12 weeks or who donated plasma or platelets within 4 weeks prior to initiation of the current study.
12. Subjects who are pregnant or under lactation, or ones who would be expected to be pregnant during the current study.
13. Subjects who participate in other clinical trials within the last one month prior to the current study.
14. Subjects who are not eligible due to physician's judgment
Target sample size 135

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Prof. Jun Nishihira, M.D.
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code
Address 59-2, nishi-nopporo, ebetsu, 069-8585, Hokkaido
TEL 011-385-4411
Email nishihira@do-johodai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Dir. Prof. Jun Nishihira, M.D.
Organization Hokkaido Information University
Division name Health Information Science Center
Zip code
Address 59-2, nishi-nopporo, ebetsu, 069-8585, Hokkaido
TEL 011-385-4430
Homepage URL
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Hokkaido small business support center
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor 1. Hokkaido milk products Co. Ltd.
2. Division of Laboratory and Transfusion Medicine, Hokkaido University Hospital
3. Roche Diagnostics K.K.
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 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
2014 Year 06 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.sciencedirect.com/science/article/pii/S2225411015000796
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
2014 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 16 Day
Last follow-up date
2014 Year 08 Month 07 Day
Date of closure to data entry
2014 Year 08 Month 20 Day
Date trial data considered complete
2014 Year 08 Month 27 Day
Date analysis concluded
2014 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 06 Month 02 Day
Last modified on
2015 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016080


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