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

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

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

Scientific Title:Acronym

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

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

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


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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name