UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042024 |
|---|---|
| Receipt number | R000047959 |
| Scientific Title | A study for evaluating the effects of intake of food containing lactic acid bacteria on immunological functions - A randomized, single-blind, placebo-controlled trial. |
| Date of disclosure of the study information | 2020/10/13 |
| Last modified on | 2021/10/21 14:58:52 |
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Basic information
Public title
A study for evaluating the effects of intake of food containing lactic acid bacteria on immunological functions - A randomized, single-blind, placebo-controlled trial.
Acronym
A study for evaluating the effects of intake of food containing lactic acid bacteria on immunological functions.
Scientific Title
A study for evaluating the effects of intake of food containing lactic acid bacteria on immunological functions - A randomized, single-blind, placebo-controlled trial.
Scientific Title:Acronym
A study for evaluating the effects of intake of food containing lactic acid bacteria on immunological functions.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of food containing lactic acid bacteria on immunological functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IgA flow rate of saliva
Key secondary outcomes
Conditioning questionnaire, concentration of IgA in saliva, saliva flow rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) 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
Food containing lactic acid bacteria for 8 weeks
Interventions/Control_2
Placebo (not containing lactic acid bacteria) 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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Males and females from 20 to 59 years of age
(2) Subjects giving written informed consent
Key exclusion criteria
(1) Individuals taking antiflatulents and/or laxatives (including purgative drug) and/or drugs which may affect immune function in common use
(2) Individuals taking antibiotics and/or drugs which may affect digestion and absorption in common use
(3) Individuals taking excessive amounts of foods containing lactic acid bacteria, bifidobacteria, natto bacteria, and/or other health foods including food for specified health use and food with function claim, which influence immune function
(4) Individuals presenting known food allergy
(5) Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period
(6) Individuals who have previous and/or current medical history of diseases (e.g., diabetes, liver disease, kidney disease, kidney disease) and/or immune-mediated diseases (e.g., atopic dermatitis, asthma, autoimmune disease)
(7) Individuals who are under treatment or have a history of drug/alcohol dependence
(8) Individuals who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics
(9) Individuals who are judged as unsuitable for the study by the investigator for the other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Ando |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory, Food material development section
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0187
andou_tomonori@lotte.co.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Ando |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory , Food material development section
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0187
Homepage URL
andou_tomonori@lotte.co.jp
Sponsor or person
Institute
Lotte Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Lotte Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Communittee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1590
jimukyoku@mail.souken-r.com
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
| 2020 | Year | 10 | Month | 13 | 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 | 10 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 16 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 16 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 16 | Day |
Date analysis concluded
| 2020 | Year | 11 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 06 | Day |
Last modified on
| 2021 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047959
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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