UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000024013
Receipt number	R000027457
Scientific 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
Date of disclosure of the study information	2016/09/16
Last modified on	2018/05/16 14:56:27

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Basic information

Public 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

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

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

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

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Satoshi Suzuki

Organization

Shinagawa season terrace health care Clinic

Division name

doctor

Zip code

Address

1-2-70 Konan, Minato-ku, Tokyo

TEL

03-3452-3381

Email

satoru_suzuki@sempos.or.jp

Public contact

Name of contact person

1st name

Middle name

Last name Fumio Namba

Organization

FUJICCO Co., Ltd.

Division name

R&D division

Zip code

Address

6-13-4 Minatojimanakamachi, Chuo-ku Kobe, Hyogo

TEL

078-303-5385

Homepage URL

Email

f-nanba@fujicco.co.jp

Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name

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)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Related information

URL releasing protocol

Publication of results

Published

Result

URL related to results and publications

http://www.lifescience.co.jp/yk/yk17/jun/ab11.html

Number of participants that the trial has enrolled

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.

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

2016 Year 08 Month 24 Day

Date of IRB

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

Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027457