UMIN-CTR Clinical Trial

Basic information
Public title	Study of the effect of a drink containing lactic acid bacteria on feeling of tiredness.
Acronym	Study of the effect of a drink containing lactic acid bacteria on feeling of tiredness.
Scientific Title	Study of the effect of a drink containing lactic acid bacteria on feeling of tiredness.
Scientific Title:Acronym	Study of the effect of a drink containing lactic acid bacteria on feeling of tiredness.
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to verify the effect on the intestinal bacterial flora, antioxidative activity and feeling of tiredness when healthy adult males and females who have a feeling of tiredness have a drink containing lactic acid bacteria every day for 12 weeks .
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Antioxidative activity (d-ROMs, BAP, 8-OHdG), oxidative stress level defined as BAP/d-ROMs
Key secondary outcomes	VAS questionnaire regarding feeling of tiredness, intestinal flora (amplicon sequence analysis)

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	Ingestion of a drink containing lactic acid bacteria for 12 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	Male and Female
Key inclusion criteria	(1)males and females from 20 to 64 years of age (2)Subjects who have a feeling of tiredness at the inspection before intervention (3)Subjects who are evaluated to have a low antioxidative activity from the result of d-ROMs and BAP value at the inspection before intervention (4)Subjects undergoing none of medical treatments (5)Subjects who have an ability to understand the purpose and contents of this clinical trial and voluntarily applied and agreed to participate in this clinical trial after the explanation of this clinical trial
Key exclusion criteria	(1)Subjects who take medicines, quasi-drugs, supplements, health foods, etc. (2)Subjects who cannot restrict the use of medicine or health foods that may influence their bowel movements after informed consent (3)Subjects who are under treatment or have a history of serious diseases (4)Subjects visiting the hospital for diseases related to bowel movements and using drugs, or regularly using commercially available constipation medicine (5)Subjects currently undergoing treatment or with digestive diseases that affect the study or have a surgical history of digestive system (except appendicectomy) (6)Subjects with diseases affecting bowel movement or have a history of these diseases (7)Subjects who drink alcohol over 1500 mL in terms of beer or smoke over average 20 cigarettes per day (8)Subjects who have a lifestyle that affect the result of this clinical trial or who plan to have such lifestyles during the test period (9)Subjects whose feeling of tiredness is caused by pain or suspected to be induced by pain (10)Subjects who are diagnosed with chronic fatigue syndrome or insomnia (11)Subjects who are diagnosed with sleep apnea syndrome or are suspected to have it (12)Subjects with a large fluctuation on defecation during menstruation or at poor physical condition (13)Subjects who have allergies to a specific drug or food (14)Subjects who have a feeling of tiredness caused by allergies to pollen, house dust, etc (15)Subjects who have participated in other clinical trial in the past one month, who have a plan to participate in other clinical trial during the test period (16)Subjects who are planned to become pregnant after submission of informed consent for this clinical trial or are pregnant or lactating (17)Subjects who are judged as unsuitable for this clinical trial by the investigator for other reasons
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Tadanobu Middle name Last name Kawagoe
Organization	Medical Topia Soka Hospital
Division name	Manager of medical department
Zip code	340-0028
Address	1-11-18, Yatsuka, Soka-shi,Saitama
TEL	048-928-3117
Email	tani@mtopia.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Kitahara
Organization	APO PLUS STATION CO., LTD.
Division name	CRO Department Clinical Operations Division
Zip code	103-0027
Address	2-14-1,Nihonbashi,Chuo-ku,Tokyo, Japan
TEL	03-6386-8809
Homepage URL
Email	y-kitahara@apoplus.co.jp

Sponsor
Institute	APO PLUS STATION CO., LTD.
Institute
Department

Funding Source
Organization	Nissin York 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	Kanazawabunko Hospital IRB
Address	2-6-22,Kamariyahigashi,Kanazawaku,Yokohama,Kanagawa, Japan
Tel	045-785-3311
Email	watanabe@kanabun-hp.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	メディカルトピア草加病院

Other administrative information
Date of disclosure of the study information	2020 Year 08 Month 03 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 07 Month 27 Day
Date of IRB	2020 Year 08 Month 07 Day
Anticipated trial start date	2020 Year 08 Month 08 Day
Last follow-up date	2020 Year 12 Month 17 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 07 Month 31 Day
Last modified on	2021 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047135