UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043697 |
|---|---|
| Receipt number | R000049896 |
| Scientific Title | Effects of Lactic Acid Bacteria on QOL: a randomized, double-blinded, placebo-controlled trial |
| Date of disclosure of the study information | 2021/03/22 |
| Last modified on | 2021/09/21 09:30:11 |
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Basic information
Public title
Effects of Lactic Acid Bacteria on QOL: a randomized, double-blinded, placebo-controlled trial
Acronym
Effects of Lactic Acid Bacteria on QOL: a randomized, double-blinded, placebo-controlled trial
Scientific Title
Effects of Lactic Acid Bacteria on QOL: a randomized, double-blinded, placebo-controlled trial
Scientific Title:Acronym
Effects of Lactic Acid Bacteria on QOL: a randomized, double-blinded, placebo-controlled trial
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of lactic acid bacteria intake on QOL.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
shortened version of POMS 2 questionnaires
Key secondary outcomes
-Mood state subjective symptoms (Athens Insomnia Scale, STAI, SF-36v2 acute version, Chalder Fatigue Scale, VAS)
-Safety (adverse events and side effects)
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
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of sachet containing lactic acid bacteria for 4 weeks
Interventions/Control_2
Intake of placebo sachet 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
Subjects between 20 to 64 years old
Key exclusion criteria
1) Subject who regularly takes foods containing Lactic acid bacteria or Bifidobacterium such as supplements, excluding yogurt.
2) Subject who regularly takes medicines or supplements that affect mood and fatigue.
3) Subject who has participated in other drug or food clinical trials within the past month.
4) Subjects who have a history of serious disorders in liver, kidney, heart, lung, gastro-intestine, blood, endocrine system, or metabolic system etc.
5) Subject with a history of drug or severe food allergy.
6) Subject who is pregnant or under lactation, or who is expected to be pregnant during the study.
7) Subject who is judged inappropriate to this trial by the investigator based on subject background, physical examination, etc.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Mitsunaga |
| Middle name | |
| Last name | Miyasaka |
Organization
Matsumoto Junior College
Division name
Department of Nursing
Zip code
3990033
Address
3118, Sasaga, Matsumoto, Nagano, Japan
TEL
0263-58-4417
mjc-m.miyasaka@matsutan.ac.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Kakiuchi |
Organization
Matsumoto Junior College
Division name
Department of Nursing
Zip code
3990033
Address
3118, Sasaga, Matsumoto, Nagano, Japan
TEL
0263-58-4417
Homepage URL
mjc-i.kakiuti@matsutan.ac.jp
Sponsor or person
Institute
Matsumoto Junior College
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
Matsumoto Junior College
Address
3118, Sasaga, Matsumoto, Nagano, Japan
Tel
0263-58-4417
mjc-m.miyasaka@matsutan.ac.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 | 03 | Month | 22 | 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 | 02 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 30 | 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 | 03 | Month | 22 | Day |
Last modified on
| 2021 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049896
