UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study for evaluating the efficacy of "Zendamakin-no-chikara" containing Lactcoccus lactis subsp. Cremoris FC on fanction of intestinal bacterial flora regulation. -Randomised double-blind placebo-controlled trial
Title of the study (Brief title)	A clinical study for evaluating the efficacy of "Zendamakin-no-chikara" containing Lactcoccus lactis subsp. Cremoris FC on fanction of intestinal bacterial flora regulation. -Randomised double-blind placebo-controlled trial
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of capsule containing Lactococcus lactis subsp. Cremoris FC on the function of intestinal regulation to subjects having tendency toward constipation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Analysation of Enterobacterial flora (number of the total bacteria, Bifidobacterium genus, Lactobaccilus genus, Clostridium Perfringens) in feces by the real-time PCR method. Time of assessment: before and two weeks after intake of active/placebo.
Key secondary outcomes	Defecation frequency per day, Defecation frequency per week, Fecal amount. Time of assessment: after two-week intake of active/placebo, defecation frequency, defecation frequency and fecal amount are assessed on a weekly basis. Fecal shape, color and odor.Feeling after defecation.

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	Capsule containing Lactococcus lactis subsp. Cremoris FC(100mg/serving) (2 weeks), washout(3 weeks), Placebo capsule(2 weeks)
Interventions/Control_2	Placebo capsule(2 weeks), washout(3 weeks), Capsule containing Lactococcus lactis subsp. Cremoris FC(100mg/serving) (2 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	30 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	(1)(Healthy) subjects aged 30 to 59 years old (2)Subjects who there were few ratios for the number of Bifidobacterium in the feces at the time of screening examination and unevenness was small (4)Subjects giving written informed consent
Key exclusion criteria	(1)Individuals taking antiflatulents and/or laxatives(including purgative drugs) in common use (2)Individuals taking health foods in common use, including food for specified health use, which influence intestinal regulation at the point of screening examination (3)Individuals taking antibiotics and/or drugs which influence laxatives(including purgative drugs) in common use at the point of screening examination (4)Individuals daily consuming alcohol as equivalent amount of sake more than 360ml (5)Individuals who are not able to stop consumption of foods containing lactic acid bacteria, bifidobacteria, natto bacteria, oligosaccharides, dietary fibers, high amount of sugar alcohol and/or other health foods including food for specified health use, which influence intestinal regulation during the study period (6)Individuals presenting known food allergy (7)Individuals who are suffered from a disease which needs treatment urgently or individuals with severe complications (8)Individuals with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation (9)Individuals infected with a disease to urgently need treatment, or having serious complications (10)Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period (11)Individuals who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics (12)Individuals who are judged as unsuitable for the study by the investigator for the other reasons
Target sample size	50

Research contact person
Name of lead principal investigator	Satoshi Suzuki
Organization	Shinagawa season terrace health care Clinic
Division name	doctor
Address	1-2-70 Konan, Minato-ku, Tokyo
TEL	03-3452-3381
Email	satoru_suzuki@sempos.or.jp

Public contact
Name of contact person	Fumio Namba
Organization	FUJICCO Co., Ltd.
Division name	R&D division
Address	6-13-4 Minatojimanakamachi, Chuo-ku Kobe, Hyogo
TEL	078-303-5385
Homepage URL
Email	f-nanba@fujicco.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	FUJICCO 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	品川シーズンテラス健診クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 24 Day
Anticipated trial start date	2016 Year 09 Month 21 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	Published
URL releasing results	http://www.lifescience.co.jp/yk/yk17/jun/ab11.html
Results	The continuous ingestion of L. lactis subsp. cremoris FC caused changes in intestinal microflora, improving defecation status and fecal characteristics in healthy subjects prone to constipation.
Other related information	Effect of Supplement containing Lactococcus lactis subsp. cremoris FC on Defecation in Healthy Humans -A Randomized, Placebo-controlled, Double-blind Crossover Trial- FUJICCO Co., Ltd. T. Toda et al. Jpn Pharmacol Ther 2017 45(6) 989-997

Management information
Registered date	2016 Year 09 Month 12 Day
Last modified on	2018 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027457