UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Lactic Acid Bacteria on QOL: An Exploratory Study.
Acronym	Effects of Lactic Acid Bacteria on QOL: An Exploratory Study.
Scientific Title	Effects of Lactic Acid Bacteria on QOL: An Exploratory Study.
Scientific Title:Acronym	Effects of Lactic Acid Bacteria on QOL: An Exploratory Study.
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 of health women.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	-Mood state subjective symptoms (shortened version of POMS 2 questionnaires, SF-36v2 acute version, VAS, CFS, PMS, PATS, AIS and other subjective symptoms scores) -Safety (adverse events and side effects)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of sachet containing lactic acid bacteria for 5 weeks
Interventions/Control_2
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	Female
Key inclusion criteria	1) Women aged 20 years or older and younger than 65 years. 2) Shortened version of POMS 2 FI (fatigue-Inertia) score is 50 or more in the first and second screenings.
Key exclusion criteria	1) Subject with hepatic disease, renal dysfunction, cardiovascular disorder, gastrointestinal disorder, respiratory dysfunction, blood disease, autoimmune disease, endocrine disease, metabolic disease and related severe past medical histories. 2) Subject who regularly takes foods containing lactic acid bacteria or bifidobacteria such as supplements, excluding yogurt. 3) Subject who regularly takes medicines and supplements that affect mood and fatigue. 4) Subject with drug allergies or severe food allergies and whom with related past medical histories. 5) Subject who is pregnant or under lactation, or who is expected to be pregnant during the study. 6) Subject who has participated in other drug or food clinical trials within the past month. 7) Subject who is judged inappropriate to this trial by the investigator based on subject background, physical examination, etc.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Fumiaki Middle name Last name Abe
Organization	Morinaga Milk Industry Co., Ltd.
Division name	Food Ingredients & Technology Institute, R&D Division
Zip code	252-8583
Address	1-83, 5-Chome, Higashihara, Zama-City, Kanagawa-Pref.
TEL	046-252-3036
Email	f_abe@morinagamilk.co.jp

Public contact
Name of contact person	1st name Natsumi Middle name Last name Mutoh
Organization	Morinaga Milk Industry Co., Ltd.
Division name	Probiotics research group, Food Ingredients & Technology Institute, R&D Division
Zip code	252-8583
Address	1-83, 5-Chome, Higashihara, Zama-City, Kanagawa-Pref.
TEL	046-252-3036
Homepage URL
Email	natsumi-mutou491@morinagamilk.co.jp

Sponsor
Institute	Morinaga Milk Industry Co., Ltd.
Institute
Department

Funding Source
Organization	None
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	Japan Conference of Clinical Research
Address	13-23, 1-Chome, Minami Ikebukuro, Toyoshima-ku, Tokyo
Tel	03-6868-7022
Email	jccr-info@jccr.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	2020 Year 08 Month 17 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 06 Month 17 Day
Date of IRB	2020 Year 06 Month 19 Day
Anticipated trial start date	2020 Year 08 Month 18 Day
Last follow-up date	2020 Year 11 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	2020 Year 08 Month 11 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/icdr_e/ctr_view.cgi?recptno=R000047249