UMIN-CTR Clinical Trial

Basic information
Public title	Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of probiotic on mood states
Acronym	Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of probiotic on mood states
Scientific Title	Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of probiotic on mood states
Scientific Title:Acronym	Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of probiotic on mood states
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the effect of Probiotic on mood states among healthy adults
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cerebral blood flow, Saliva Stress Index, Questionnaire
Key secondary outcomes

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	Intake of powdered probiotic for 6 weeks
Interventions/Control_2	Intake of powdered placebo for 6 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) Subjects of both sexes aged 20 years or older and younger than 65 years.
Key exclusion criteria	1) Subjects with serious disorders on hepatic, kidney, cardiac, lung, digestive organs, blood, endocrine system, mental and metabolic system, or related severe past medical histories 2) Subjects who are under alternative treatment (acupuncture, chiropractic and etc.) or with treatment histories of within 1 month 3) Subjects with suicide thoughts 4) Subjects who regularly take foods containing Lactic acid bacteria or Bifidobacterium such as supplements 5) Subjects who regularly intake medical drugs or supplements that affect moods or fatigue 6) Subjects with medication allergy, food allergy, or serious history of these 7) Subjects who are pregnant, under lactation or expecting to be pregnant during this study 8) Subjects who participated in other study within 1 month prior to obtaining informed consent 9) Any candidates considered to be inappropriate for this study by the principal investigator based on their background, physical examination, etc.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hirotaka Middle name Last name Nagashima
Organization	Medical Corporation Chisei-kai Tokyo Center Clinic
Division name	Clinical Research Center
Zip code	103-0028
Address	Yaesu KT Bldg 1-1-8 Yaesu, Chuo-ku, Tokyo, Japan
TEL	03-3276-6935
Email	nagashima_hirotaka@tc-clinic.jp

Public contact
Name of contact person	1st name Shigeru Middle name Last name Imai
Organization	Leverage Brain Inc.
Division name	Clinical Trial Department
Zip code	105-0004
Address	Shinbashi2-16-1 Minato-ku, Tokyo, Japan
TEL	080-7290-0404
Homepage URL
Email	imai@levbrain.com

Sponsor
Institute	Leverage Brain Inc.
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	Japan Conference of Clinical Research
Address	1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
Tel	03-6868-7022
Email	jccr-info@cts-smo.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	医療法人社団　知正会　東京センタークリニック（東京都）

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 14 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	Preinitiation
Date of protocol fixation	2021 Year 07 Month 05 Day
Date of IRB	2021 Year 08 Month 19 Day
Anticipated trial start date	2021 Year 09 Month 15 Day
Last follow-up date	2021 Year 11 Month 28 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 08 Month 23 Day
Last modified on	2021 Year 08 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051670