UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010813
Receipt number R000012600
Scientific Title A randamized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of oral administration of probiotic LKM512 in individuals with pre-arteriosclerosis
Date of disclosure of the study information 2013/05/27
Last modified on 2015/11/27 15:27:40

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Basic information

Public title

A randamized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of oral administration of probiotic LKM512 in individuals with pre-arteriosclerosis

Acronym

Effects of probiotics LKM512 in individuals with pre-arteriosclerosis: double-blind, placebo-controlled parallel group study

Scientific Title

A randamized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of oral administration of probiotic LKM512 in individuals with pre-arteriosclerosis

Scientific Title:Acronym

Effects of probiotics LKM512 in individuals with pre-arteriosclerosis: double-blind, placebo-controlled parallel group study

Region

Japan


Condition

Condition

Patients with high levels of serum triglyceride

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of oral administration of bifidobacteria LKM512 on inflammation-related markers in patients with high levels of serum triglyceride

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Inflammation-related markers (CoQ10, adiponectine, ICAM-a, TNF-alpha, s-LOX, LAB)

Key secondary outcomes



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

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

The volunteer were given an 12-week treatment with oral administration of bifidobacteria LKM512 powder (10 billion bacterial cells/package) two times per day.

Interventions/Control_2

The volunteer were given an 12-week treatment with oral administration of placebo powder without bifidobacteria LKM512 two times per day.

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

Outpatients whose serum triglyceride level is 100 to 250 mg/dL

Key exclusion criteria

(1)Subjects who are undergoing dyslipidemia treatment
(2)Subjects who take medicine that influencea value of cholesterol
(3)Seriouse subjects who have complications with cardiac disease, hepatic disease, and/or renal disease
(4)Subjects who was enrolled in other trails within three month.
(5)Inappropriate cases evaluated by doctors

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuharu Matsumoto

Organization

Kyodo Milk Industry Co. Ltd.

Division name

Research Laboratories

Zip code


Address

20-1 Hirai, Hinode-machi, Nishitama-gun, Tokyo 190-0182

TEL

042-597-5911

Email

m-matumoto@meito.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Sakurai

Organization

Imeq CO. Ltd.

Division name

CRO division

Zip code


Address

4-17-15 Takadanobaba, Shinjuku-ku, Tokyo

TEL

03-6279-3591

Homepage URL


Email

s-sakurai@imeq.co.jp


Sponsor or person

Institute

Kyodo Milk Industry Co. Ltd.

Institute

Department

Personal name



Funding Source

Organization

Kyodo Milk Industry 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



Other administrative information

Date of disclosure of the study information

2013 Year 05 Month 27 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

Open public recruiting

Date of protocol fixation

2013 Year 04 Month 22 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 30 Day

Last follow-up date

2013 Year 10 Month 10 Day

Date of closure to data entry

2013 Year 10 Month 30 Day

Date trial data considered complete

2013 Year 11 Month 06 Day

Date analysis concluded

2013 Year 11 Month 06 Day


Other

Other related information



Management information

Registered date

2013 Year 05 Month 27 Day

Last modified on

2015 Year 11 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012600


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name