UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044729
Receipt number R000051069
Scientific Title Safety evaluation of excessive intake of food containing lactic acid bacteria
Date of disclosure of the study information 2021/07/01
Last modified on 2021/12/21 15:34:38

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Basic information

Public title

Safety evaluation of excessive intake of food containing lactic acid bacteria

Acronym

Safety evaluation of excessive intake of food containing lactic acid bacteria

Scientific Title

Safety evaluation of excessive intake of food containing lactic acid bacteria

Scientific Title:Acronym

Safety evaluation of excessive intake of food containing lactic acid bacteria

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To study the safety of a daily intake of 300mL of a test food containing lactic acid bacteria for 4 consecutive weeks.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Hematologic test
Blood biochemistry test
Urine analysis
Blood pressure/pulsation
Body weight/body mass index
Doctor's question
Adverse event

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of test food for 4 consecutive weeks

Interventions/Control_2


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

64 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy males and females from 20 to 64 years old

Key exclusion criteria

(1) Subjects who are judged as unsuitable for the study based on the results of the lifestyle questionnaire
(2) Subjects who have serious disease or history of those illnesses (e.g., diabetes, liver disease, kidney disease, heart disease, respiratory disease, endocrine diseases, or metabolic disease)
(3) Subjects who are judged as unsuitable for the study based on the results of clinical examination or cardiopulmonary abnormality
(4) Subjects having possibilities for emerging allergy related to the study
(5) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(6) Subjects who have participated in other clinical studies
(7) Subjects who intend to become pregnant or lactating during the test period
(8) Subjects judged as unsuitable for the study by the investigator for other reasons

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Kenji
Middle name
Last name Uchida

Organization

Yotsuba Milk Products Co., Ltd.

Division name

Research Division R&D Center

Zip code

061-1264

Address

465-1,Wattsu,Kitahiroshima-shi,Hokkaido

TEL

011-377-5561

Email

uchida_k@yotsuba.co.jp


Public contact

Name of contact person

1st name Nahomi
Middle name
Last name Noji

Organization

EP Mediate Co., Ltd.

Division name

Development Business Headquarters, TTC Center, Trial Planning Department

Zip code

162-0822

Address

Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo

TEL

03-5657-4983

Homepage URL


Email

noji590@eps.co.jp


Sponsor or person

Institute

EP Mediate Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Yotsuba Milk Products 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

Medical Station Clinic Research Ethics Committee

Address

3-12-8, Takaban, Meguro-ku, Tokyo

Tel

03-6452-2712

Email

saito876@eps.co.jp


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

2021 Year 07 Month 01 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

2021 Year 06 Month 10 Day

Date of IRB

2021 Year 06 Month 10 Day

Anticipated trial start date

2021 Year 07 Month 02 Day

Last follow-up date

2021 Year 09 Month 21 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 07 Month 01 Day

Last modified on

2021 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051069


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name