UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032285
Receipt number R000036817
Scientific Title Safety excessive intake study of drink-B containing lactic acid bacteria
Date of disclosure of the study information 2018/04/23
Last modified on 2018/08/24 13:02:00

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Basic information

Public title

Safety excessive intake study of drink-B containing lactic acid bacteria

Acronym

Safety excessive intake study of drink-B containing lactic acid bacteria

Scientific Title

Safety excessive intake study of drink-B containing lactic acid bacteria

Scientific Title:Acronym

Safety excessive intake study of drink-B containing lactic acid bacteria

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Confirm the safety of the beverage containing Lactobacillus casei NY 1301 strain on healthy adults,3-fold quantity of recommended daily intake for 4 weeks.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Frequency of side effects

Key secondary outcomes

Frequency of adverse events, Physical examination, Blood test, Urinalysis, Background factors, Lifestyle background


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

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of drink containing lactic acid bacteria for 4 weeks.(3-fold quantity of recommended daily intake)

Interventions/Control_2

Intake of placebo drink for 4 weeks.(3-fold quantity of recommended daily intake)

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

70 years-old >

Gender

Male and Female

Key inclusion criteria

1)Subjects from 20 to 69 years-old
2)Subjects undergoing none of medical treatments
3)Subjects who can record daily logs daily during the designated period
4)Subjects who can record daily logs during the designated period
5)Subjects who can record diet records on specified days

Key exclusion criteria

1)Subjects with serious liver disease,renal /heart disease,organ disorder,diabetes,food allergy,gastrointestinal disease,other serious diseases
2)Subjects allergic to a specific drug or food
3)Subjects allergic to samples in this study
4)Pregnants,lactating women or who is going to be pregnant during study
5)Subjects drawn blood over 200mL last 1 month, or over 400mL last3 months before consent acquisition date
6)Subjects who can't maintain everyday life habits
7)Subjects with a several variation of the amount of diet or movement
8)Subjects drink alcohol over 500mL in terms of beer per day
9)Subjects smoke over average 20 cigarettes per day
10)Subjects who can not refrain from using health foods, during the study
11)Subjects who can not take the test food as instructed
12)Subjects who have participated in the other clinical studies
13)Subjects judged as unsuitable for the study by the principal investigator for other reasons

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Moriyama

Organization

Kanazawabunko Hospital

Division name

Vice president

Zip code


Address

2-6-22,Kamariyahigashi,Kanazawa-ku, Yokohama-shi,Kanagawa

TEL

045-785-3311

Email

watanabe@kanabun-hp.jp


Public contact

Name of contact person

1st name
Middle name
Last name Natsumi Oka

Organization

APO PLUS STATION CO., LTD.

Division name

CRO Department Food Test Division

Zip code


Address

2-14-1,Nihonbashi,Chuo-ku,Tokyo

TEL

03-6386-8809

Homepage URL


Email

n2-oka@apoplus.co.jp


Sponsor or person

Institute

APO PLUS STATION CO., LTD.

Institute

Department

Personal name



Funding Source

Organization

Nissin York 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

金沢文庫病院(神奈川県)、ゆきクリニック(東京都)、戸田中央総合病院(埼玉県)


Other administrative information

Date of disclosure of the study information

2018 Year 04 Month 23 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

Completed

Date of protocol fixation

2018 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 04 Month 23 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 04 Month 17 Day

Last modified on

2018 Year 08 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036817


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name