UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study for evaluating the effects of lactic acid bacteria FK-23 on controlling intestinal functions (improvement of bowel movement)
Title of the study (Brief title)	A clinical study for evaluating the effects of lactic acid bacteria FK-23 on controlling intestinal functions (improvement of bowel movement)
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of 2-week intake of lactic acid bacteria FK-23 on controlling intestinal functions in healthy volunteers with a tendency to be constipated
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation frequency
Key secondary outcomes	Population of bifidobacterium to total bacteria, feeling after defecation, smell of feces, defecation days, fecal condition

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	4
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Powder food containing FK-23 (0.25 g)
Interventions/Control_2	Powder food containing FK-23 (0.075 g)
Interventions/Control_3	Powder food containing FK-23 (0.025 g)
Interventions/Control_4	Powder food not containing FK-23 (placebo)
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)Healthy subject within 20-65 years of age, both genders, with constipation tendency (with defecation frequency from 3 to 5 times per week) 2)Subject having a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent
Key exclusion criteria	1)Subject receiving treatment for gastrointestinal diseases 2)Subject having a medical history with organic constipation or irritable bowel syndrome 3)Subject taken medicines for intestinal disorder or laxatives 4)Subject taking medicine, quasi-drugs, food for specified health uses or foods with functional claims having the effects for intestinal functions 5)Subject having serious liver diseases, cardiovascular, respiratory, endocrine or metabolic disorders, or having a medical history with them 6)Subject have a medical history with test food-ralated allergy 7)Female subject who is pregnant or lactating, or intending to become pregnant during the study 8)Subject who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 9)Subject deemed unsuitable by the investigator
Target sample size	60

Research contact person
Name of lead principal investigator	Osami Kajimoto
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Medical Science on Fatigue
Address	1-4-3 Asahi-machi, Abeno-ku, Osaka
TEL	06-6645-6171
Email	kajimoto@med.osaka-cu.ac.jp

Public contact
Name of contact person	Tomohiro Sugino
Organization	Soiken Inc.
Division name	R&D Division
Address	Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL	06-6871-8888
Homepage URL
Email	sugino@soiken.com

Sponsor
Institute	Soiken Inc.
Institute
Department

Funding Source
Organization	Nichinichi Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 05 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 19 Day
Anticipated trial start date	2016 Year 02 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 19 Day
Last modified on	2019 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024203