UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045564 |
|---|---|
| Receipt number | R000051982 |
| Scientific Title | A randomized, placebo-controlled, double-blind, parallel-group comparison study for the effects of probiotics on the immune function in healthy adult |
| Date of disclosure of the study information | 2021/09/26 |
| Last modified on | 2022/10/09 17:54:00 |
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Basic information
Public title
A randomized, placebo-controlled, double-blind, parallel-group comparison study for the effects of probiotics on the immune function in healthy adult
Acronym
A randomized, placebo-controlled, double-blind, parallel-group comparison study for the effects of probiotics on the immune function in healthy adult
Scientific Title
A randomized, placebo-controlled, double-blind, parallel-group comparison study for the effects of probiotics on the immune function in healthy adult
Scientific Title:Acronym
A randomized, placebo-controlled, double-blind, parallel-group comparison study for the effects of probiotics on the immune function in healthy adult
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily verify some kind of effect induced by probiotic intakes on immune function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cell surface marker
Key secondary outcomes
1. Neutrophilic phagocytosis
2. Neutrophilic bactericidal ability
3. NK cell activity
4. Cytokines (INF-alpha, INF-beta, INF-gamma, IL-6, IL-12, etc.)
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
Oral ingestion of the test food to the subjects, one package a day for 4 weeks.
Interventions/Control_2
Oral ingestion of the placebo food to the subjects, one package a 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) Healthy male/female subjects Healthy male/female subjects aged more than 20 years, less than 65 years.
(2) Subjects who can give informed consent to take part in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Subjects who are under some kind of continuous medical treatment for malignant tumor, respiratory disease, liver, kidney, heart, lung, digestive organ, blood, endocrine/metabolic system, etc., or have a previous medical history of related serious diseases.
(2) Subjects who have drug allergy or severe food one, and/or a previous medical history of those.
(3) Pregnant, possibly pregnant, and lactating women.
(4) Subjects who are affected by an autoimmune disease.
(5) Subjects who have excessive alcoholic drinks.
(6) Subjects who are equipped with lactose intolerance constitutionally.
(7) Subjects who will take medicine (e.g., antiallergics and antibiotics) during the screening test period, which might affect their immune function, or are taking a specified food containing bifidobacteria, lactic acid bacteria, and so on.
(8) Subjects who took part in another clinical study within 28 days before giving informed consent to participate in this study, or are planning to take part in another one during this study.
(9) Subjects who donated 400 mL of their blood within twelve weeks before the beginning of test-food intakes, or not less than 200 mL of their blood during the screening test period.
(10) Subjects who were vaccinated against pandemics such as influenza, novel coronavirus, etc., within a month before prior examination, or are planning to vaccinate them against those viruses before the completion of this study.
(11) Others who have been determined as ineligible for the research subject of this study, judging from the principal/sub investigator's opinions on the findings of their background, physical observations, medical checkup, physical/clinical examination, and so on.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.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 | 09 | Month | 26 | 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
| 2021 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 17 | 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 | 09 | Month | 24 | Day |
Last modified on
| 2022 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051982
