UMIN-ICDS Clinical Trial

Public title

A study for safety evaluation of Long-Term intake of Probiotics -A Randomized, Double-Blind, Placebo-Controlled trial-

Acronym

A study for safety evaluation of Long-Term intake of Probiotics -A Randomized, Double-Blind, Placebo-Controlled trial-

Scientific Title

A study for safety evaluation of Long-Term intake of Probiotics -A Randomized, Double-Blind, Placebo-Controlled trial-

Scientific Title:Acronym

A study for safety evaluation of Long-Term intake of Probiotics -A Randomized, Double-Blind, Placebo-Controlled trial-

Region

Japan

Condition

Male/female adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Evaluate the long-term safety of probiotic intake in healthy adult subjects by taking probiotic powder for 12 weeks.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Questionnaire
Physical measurement (height, weight (BMI))
Blood pressure and pulse rate
Hematology
Biochemistry
Urinalysis
Self and other symptoms
Adverse events and side effects

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Consumption of the test food (1 sachet a day) for 12 weeks

Interventions/Control_2

Consumption of the placebo food (1 sachet a day) for 12 weeks

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

18

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1.Subjects who are age of at least 18 years of age and less than 65 years.
2.Subjects who received an enough explanation of the test objectives and detail, who have consent ability, who are willing to participate with well understandings and who have signed the informed consent document.

Key exclusion criteria

1.Subjects who have a history of serious illness.
2.Subjects who are under treatment with medication for chronic diseases.
3.Subjects who are unable to discontinue foods or supplements containing lactic acid bacteria, bifidobacteria, oligosaccharides, etc. during the study period.
4.Subjects who have digestive tract diseases that affect digestion and absorption, and have had a history of gastrointestinal surgery (excluding appendicitis).
5.Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
6.Subjects who are planning to participate in other clinical studies.
7.Subjects with a history of drug allergies or severe food allergies.
8.Subjects who are pregnant or under lactation, or who is expected to be pregnant during the study period.
9.Heavy alcohol drinkers (average of more than 20g of alcohol/day in terms of pure alcohol).
10.Excessive smokers (21 or more cigarettes per day).
11.Subjects who have been diagnosed with dry mouth.
12.Subjects who have had more than 400 mL of blood drawn within 12 weeks prior to the start of intake, or more than 200 mL of blood drawn during the previous observation period.
13.Subjects who have been deemed unsuitable as study participants by the principal investigator or sub-investigator based on their background, physical examination, blood pressure, pulse rate, and clinical test results.

Target sample size

40

Name of lead principal investigator

1st name	Daisuke
Middle name
Last name	Tsuge

Organization

Shinagawa Season Terrace Health Care Clinic

Division name

Doctor

Zip code

108-0075

Address

1-2-70, Konan, Minato-ku, Tokyo The 5th floor of Shinagawa season terrace

TEL

03-3452-3382

Email

shibaura@sempos.or.jp

Name of contact person

1st name	Eiji
Middle name
Last name	Yoshikawa

Organization

KSO Corporation

Division name

Clinical Trial Management department

Zip code

105-0023

Address

1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building

TEL

03-3452-7733

Homepage URL

Email

eigyou27@kso.co.jp

Institute

KSO Corporation

Institute

Department

Personal name

Organization

Morinaga Milk Industry Co., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Committee of Kobuna Orthopedics Clinic

Address

5-656-17Joutou-machi,Maebashi-shi,Gunma

Tel

027-212-5608

Email

sagawa@mc-connect.co.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

2024

Year

04

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

11

Month

20

Day

Date of IRB

2023

Year

11

Month

20

Day

Anticipated trial start date

2024

Year

05

Month

24

Day

Last follow-up date

2024

Year

11

Month

02

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

12

Month

27

Day

Last modified on

2024

Year

03

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060757