UMIN-ICDS Clinical Trial

Public title

Investigation of the effects of lactic acid bacteria-containing food intake on the intestinal environment

Acronym

Investigation of the effects of lactic acid bacteria-containing food intake on the intestinal environment

Scientific Title

Investigation of the effects of lactic acid bacteria-containing food intake on the intestinal environment

Scientific Title:Acronym

Investigation of the effects of lactic acid bacteria-containing food intake on the intestinal environment

Region

Japan

Condition

Healthy male/female adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Evaluate the effect of lactic acid bacteria (LAB) -containing food on the tendency to defecate and the intestinal environment for people prone to constipation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Defecation frequency

Key secondary outcomes

1. Defecation status (frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, odor)
2. Gut microbiota
3. Gut metabolomes
4. Abdominal symptoms (bloating, belching, gas (flatus frequency)) at times other than during defecation

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 test food 1 (2 capsules per day for 8 weeks)

Interventions/Control_2

Consumption of test food 2 (2 capsules per day for 8 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

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

(1) At informed consent, male/female subjects aged more than or equal to 20, and less than 65 years old.
(2) Defecation frequency is between 3 and 5 times a week.
(3) Subjects who can show their understanding of the study procedure and agreement with participating in the study by informed consent prior to the study.

Key exclusion criteria

(1) Subjects who are unable to discontinue consumption of products containing LAB (refers to those clearly indicated as ingredients, excluding those contained in the food as a result of the manufacturing process) from the time consent is obtained, or those who plan to consume such products during the study.
(2) Subjects who are unable to discontinue consumption of foods for specified health uses, foods with function claims, health foods that may affect the study (intestinal regulation, etc.) from the time consent is obtained.
(3) Subjects who are unable to discontinue consumption of supplements (including tablets, capsules, and other forms distinct from ordinary foodstuffs, taken for nutritonal or functional puposes regardless of ingredients or functionality) from the time consent is obtained.
(4) Subjects who have taken drugs (antibiotics, antiflatulent, laxatives, etc.) that would affect the study one month prior to the pre-test, or those sho plant to take during the study.
(5) Subjects with a history of appendectomy.
(6) Subjects who have undergone surgery that may affect the study (colonoscopy, removal of gallstones or gall bladder, gastric bypass surgery, bariatric surgery, etc.) within 6 months prior to obtaining consent.
(7) Subjects who are expected to undergo a major change in their family, work, or other living environment (e.g., relocation, transfer, etc.) during the study.
(8) Subjects with extremely irregular eating habits.
(9) Subjects whose roommates plan to participate in the study.
(10) Smokers.
(11) Heavy alcohol drinkers.
(12) Subjects with a history of serious diseases of the heart, liver, kidneys, digestive organs, etc.
(13) Pregnant, lactating, or intending to become pregnant during the study.
(14) Subjects allergic to medicines and foods.

(Due to character limitation, the following will be listed in the "Others" section)

Target sample size

16

Name of lead principal investigator

1st name	Tatsuhiro
Middle name
Last name	Nomaguchi

Organization

Metagen, Inc.

Division name

Product Development Support Division

Zip code

997-0052

Address

246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata 997-052, Japan

TEL

+81-235-64-0330

Email

research@metagen.co.jp

Name of contact person

1st name	Fumiko
Middle name
Last name	Nakamura

Organization

CPCC Company Limited

Division name

Clinical Support Division

Zip code

103-0021

Address

4F Daiwa Building, 3-3-10 Nihonbashi-Hongokucho, Chuo-ku, Tokyo, Japan

TEL

+81-3-6225-9001

Homepage URL

Email

cpcc-contact@cpcc.co.jp

Institute

Metagen, Inc.

Institute

Department

Personal name

Organization

ITO EN, LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Daiwa Building, 3-3-10 Nihonbashi-Hongokucho, Chuo-ku, Tokyo 103-0021, Japan

Tel

+81-3-6225-9005

Email

IRB@cpcc.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

2025

Year

11

Month

10

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

2025

Year

10

Month

27

Day

Date of IRB

2025

Year

10

Month

24

Day

Anticipated trial start date

2025

Year

11

Month

28

Day

Last follow-up date

2026

Year

03

Month

19

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

(Continuing from exclusion criteria)
(15) Participating in a clinical study of another drug or health food, within 4 weeks of the completion of the study, or who is scheduled to participate in another clinical study after consent to participate in this study.
(16) Subjects who have donated 200 mL of blood in one month before start of the study.
(17) Males who have donated 400 mL of blood within 3 months before start of the study.
(18) Females who have donated 400 mL of blood within 4 months before start of the study.
(19) Males whose blood collected in the 12 months before study plus the expected blood for the study exceeds 1200 mL.
(20) Females whose blood collected in the 12 months before study plus the expected blood for the study exceeds 800 mL.
(21) Those who are judged by the principal investigator or sub-investigator to be inappropriate to participate in this study.

Registered date

2025

Year

11

Month

10

Day

Last modified on

2025

Year

11

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068304