UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035241
Receipt number R000040153
Scientific Title A study for evaluating the viability of lactic acid bacteria in intestinal tract after ingestion of food containing lactic acid bacteria. Second report, an open trial.
Date of disclosure of the study information 2018/12/13
Last modified on 2019/12/19 10:42:34

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Basic information

Public title

A study for evaluating the viability of lactic acid bacteria in intestinal tract after ingestion of food containing lactic acid bacteria. Second report, an open trial.

Acronym

A study for evaluating the viability of lactic acid bacteria in intestinal tract after intake of food containing lactic acid bacteria, second report

Scientific Title

A study for evaluating the viability of lactic acid bacteria in intestinal tract after ingestion of food containing lactic acid bacteria. Second report, an open trial.

Scientific Title:Acronym

A study for evaluating the viability of lactic acid bacteria in intestinal tract after intake of food containing lactic acid bacteria, second report

Region

Japan


Condition

Condition

Healthy volunteers

Classification by specialty

Gastroenterology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate whether viable Lactobacillus brevis is detected in the feces after ingestion of food containing lactic acid bacteria for healthy volunteers.

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Number of viable Lactobacillus brevis in the feces

Key secondary outcomes

Number of Lactobacillus genus in the feces, number of Bifidobacterium genus in the feces, number of total bacteria in the feces, organic acids content in feces, decay product content in feces


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

Food containing lactic acid bacteria

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

60 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Males and females from 20 to 59 years of age
(2) Subjects giving written informed consent

Key exclusion criteria

(1) Individuals taking antiflatulents and/or laxatives (including purgative drug) and/or health foods in common use, including food for specified health use and food with function claim
(2) Individuals taking antibiotics and/or drugs which influence laxatives(including purgative drugs) in common use
(3) Individuals who are not able to stop consumption of foods containing lactic acid bacteria, bifidobacteria, oligosaccharides, dietary fibers, high amount of sugar alcohol and/or other health foods including food for specified health use and food with function claim, which influence intestinal regulation during the study period
(4) Individuals presenting known food allergy
(5) Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period
(6) Individuals who are under treatment or have a history of drug/alcohol dependence
(7) Individuals who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics
(8) Individuals who are judged as unsuitable for the study by the investigator

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Keishiro
Middle name
Last name Yoshida

Organization

Lotte Co., Ltd.

Division name

Central Laboratory

Zip code

336-8601

Address

1-1, Numakage-3chome, Minami-ku, Saitama

TEL

048-837-0275

Email

yoshida_keishirou@lotte.co.jp


Public contact

Name of contact person

1st name Keishiro
Middle name
Last name Yoshida

Organization

Lotte Co., Ltd.

Division name

Central Laboratory

Zip code

336-8601

Address

1-1, Numakage-3chome, Minami-ku, Saitama

TEL

048-837-0275

Homepage URL


Email

yoshida_keishirou@lotte.co.jp


Sponsor or person

Institute

Lotte Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical Committee of Nihonbashi Cardiology Clinic

Address

13-4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo

Tel

03-5641-4133

Email

niho-jimucho@well-sleep.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

2018 Year 12 Month 13 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

10

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 12 Month 05 Day

Date of IRB

2018 Year 12 Month 05 Day

Anticipated trial start date

2018 Year 12 Month 14 Day

Last follow-up date

2019 Year 02 Month 18 Day

Date of closure to data entry

2019 Year 03 Month 21 Day

Date trial data considered complete

2019 Year 04 Month 03 Day

Date analysis concluded

2019 Year 04 Month 16 Day


Other

Other related information



Management information

Registered date

2018 Year 12 Month 13 Day

Last modified on

2019 Year 12 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040153


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name