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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043697
Receipt No. 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

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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
Email 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
Email mjc-i.kakiuti@matsutan.ac.jp

Sponsor
Institute Matsumoto Junior College
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049896

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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