UMIN-ICDS Clinical Trial

Public title

Safety evaluation of overdose intake of foods containing Lactobacillus brevis subsp. coagulans (Labre)

Acronym

Safety evaluation of overdose intake of foods containing Lactobacillus brevis subsp. coagulans (Labre)

Scientific Title

Safety evaluation of overdose intake of foods containing Lactobacillus brevis subsp. coagulans (Labre)

Scientific Title:Acronym

Safety evaluation of overdose intake of foods containing Lactobacillus brevis subsp. coagulans (Labre)

Region

Japan

Condition

Healthy adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To confirm safety of overdose intake of foods containing Labre

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change of the values of physical test, hematological test, blood biochemistry test and urinalysis, and the number of adverse events

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Test food: Food containing Labre

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

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

(1) Healthy Japanese males and females between 20 and 65 years of age, or Japanese males and females with constipation tendency (defecation frequency less than 4 times/week)
(2) Subjects who can be available at the research site on the designated dates
(3) Subjects who have received sufficient explanations about the purpose and content of this study, have the ability to consent, volunteer to participate in this study in writing with a good understanding.

Key exclusion criteria

(1) Subjects who have a history of heart, liver, kidney disease, organ damage, diabetes, or other serious diseases
(2) Subjects who have a history of gastrointestinal surgery (excluding appendectomy)
(3) Subjects who are currently receiving medical drug treatment
(4) Subjects who are pregnant, wish to become pregnant during the study, or are breastfeeding
(5) Subjects who take foods or supplements containing lactobacilli or bifidobacteria 3 times or more a week (Suguki pickle, bran pickle, kimchi, "Labre capsules", etc.)
(6) Shift workers, including late-night shifts
(7) Subjects who drink more than 60 g pure alcohol equivalent/day on average
(8) Subjects who smoke an average of 21 cigarettes or more per day
(9) Subjects who donated blood within 3 months at screening
(10) Subjects who are participating in clinical research or monitoring (food, pharmaceuticals, cosmetics) other than this research, or plan to participate during this research period
(11) Subjects who are judged to be inappropriate for this study with other reasons by the principal investigator.

Target sample size

20

Name of lead principal investigator

1st name	Kazuhiko
Middle name
Last name	Takano

Organization

Medical Corporation Hokubukai Utsukushigaoka Hospital

Division name

Clinical Pharmacology Center

Zip code

004-0839

Address

61-1. Sinei, Kiyota-ku, Sapporo, Hokkaido 004-0839 Japan

TEL

0118820111

Email

takano@ughp-cpc.jp

Name of contact person

1st name	Takuya
Middle name
Last name	Matsuda

Organization

Medical Corporation Hokubukai Utsukushigaoka Hospital

Division name

Clinical Pharmacology Center

Zip code

004-0839

Address

61-1. Sinei, Kiyota-ku, Sapporo, Hokkaido 004-0839 Japan

TEL

011-882-0111

Homepage URL

Email

matsuda@ughp-cpc.jp

Institute

Medical Corporation Hokubukai Utsukushigaoka Hospital

Institute

Department

Personal name

Organization

Shinwayakuhin Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Corporation Hokubukai Utsukushigaoka Hospital Ethics Review Committee

Address

61-1, Shinei, Kiyota-ku, Sapporo, Hokkaido, 004-0839, Japan

Tel

011-882-0111

Email

matsuda@ughp-cpc.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

11

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

20

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

Recruitment status

No longer recruiting

Date of protocol fixation

2023

Year

10

Month

13

Day

Date of IRB

2023

Year

10

Month

19

Day

Anticipated trial start date

2023

Year

11

Month

08

Day

Last follow-up date

2023

Year

12

Month

20

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

11

Month

07

Day

Last modified on

2023

Year

11

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060155