UMIN-ICDS Clinical Trial

Public title

A verification study of the effects of consumption of the test food on the bowel movement

Acronym

A verification study of the effects of consumption of the test food on the bowel movement

Scientific Title

A verification study of the effects of consumption of the test food on the bowel movement: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

A verification study of the effects of consumption of the test food on the bowel movement

Region

Japan

Condition

Healthy Japanese

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of consumption of the test food on the bowel movement in healthy Japanese.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. The measured value of defecation frequency in period 5*

*Period 5: From 22 days after intervention to the day before four weeks after intervention (4w)

Key secondary outcomes

1. The measured values of defecation frequency in period 2, 3, and 4*

* Period 2: 1~7 days after intervention
Period 3: 8~14 days after intervention
Period 4: From 15 days after intervention to the day before three weeks after intervention

2. The changes and percentage changes of defecation frequency from period 1* in period 2, 3, 4, and 5.

* Period 1: For 7 days prior to screening (Scr)

3. The measured values, the changes and percentage changes from period 1 of defecation days and amount of defecation in period 2, 3, 4, and 5

4. Individuals whose stool shape, stool smell, and exhilarating feeling of defecation improved by one or more scales in period 2, 3, 4, and 5 compared to period 1

5. The measured values, the changes and percentage changes from Scr acetic acid, propionic acid, succinic acid, lactic acid, iso-butyric acid, iso-valeric acid, n-butyric acid, n-valeric acid, and formic acid at 4w

6. Individuals who experienced adverse events

7. Individuals whose urinalysis and peripheral blood test values were within the reference range at Scr but became outside the reference range after intervention

8. Physical measurements, urinalysis, and peripheral blood test

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

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Duration: Four weeks
Test product: Food containing Bifidobacterium longum KMH001
Administration: Take one capsule with water per day at any time during the day

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.

Interventions/Control_2

Duration: Four weeks
Test product: Placebo food
Administration: Take one capsule with water per day at any time during the day

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Adults

4. Healthy individuals

5. Individuals whose defecation frequency is three to five times per week

Key exclusion criteria

1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction

2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator

3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims

5. Individuals who are taking or using medications (including herbal medicines) or supplements

6. Individuals who habitually drink more than 60 g/day of alcohol

7. Individuals who have surgical history of digestive organs

8. Individuals who are allergic to medications or foods related to the test product

9. Individuals who are pregnant, lactating, or planning pregnancy during this study

10. Individuals who are deemed unsuitable for participation in this study by the principal investigator

Target sample size

30

Name of lead principal investigator

1st name	Tsuyoshi
Middle name
Last name	Takara

Organization

Medical Corporation Seishinkai, Takara Clinic

Division name

Director

Zip code

141-0022

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

TEL

03-5793-3623

Email

t-takara@takara-clinic.com

Name of contact person

1st name	Naoko
Middle name
Last name	Suzuki

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

KITII Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

Tel

03-5793-3623

Email

IRB@takara-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Date of disclosure of the study information

2026

Year

07

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

Open public recruiting

Date of protocol fixation

2026

Year

06

Month

24

Day

Date of IRB

2026

Year

06

Month

24

Day

Anticipated trial start date

2026

Year

07

Month

10

Day

Last follow-up date

2026

Year

10

Month

12

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

07

Month

10

Day

Last modified on

2026

Year

07

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071186