UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food on the intestinal environment in healthy Japanese subjects

Acronym

Effects of consumption of the test food on the intestinal environment in healthy Japanese subjects

Scientific Title

Effects of consumption of the test food on the intestinal environment in healthy Japanese subjects: a randomized, active-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

Effects of consumption of the test food on the intestinal environment in healthy Japanese subjects

Region

Japan

Condition

Healthy Japanese subjects

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 intestinal environment in healthy Japanese subjects

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. The intestinal flora at four weeks after consumption (4w)

Key secondary outcomes

1. Acetic acid, propionic acid, isobutyric acid, n-butyric acid, isovaleric acid, n-valeric acid, lactic acid, succinic acid, formic acid, and CAS score in the Japanese Version of the Constipation Assessment Scale Middle Term version (CAS-MT) at 4w

2. The numbers of defecation days, the defecation frequency, and the amount of defecation in period 3~6*

3. Stool shape, stool color, stool smell, and exhilarating feeling of defecation in period 3~6*

4. The abdominal discomfort in period 1~4*

5. Each item of CAS-MT at 4w

*Period 1: Seven days prior to screening (before consumption: Scr)
Period 2: Seven days prior to pre-consumption assessment
Period 3: The 1st week after consumption of the test food
Period 4: The 2nd week after consumption of the test food
Period 5: The 3rd week after consumption of the test food
Period 6: The 4th week after consumption of the test food

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

YES

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: Four weeks
Test food: Food containing coated bifidobacteria
Administration: Take one packet with water or as it is and swallow it without chewing

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Interventions/Control_2

Duration: Four weeks
Test food: Food containing bifidobacteria
Administration: Take one packet with water or as it is and swallow it without chewing

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next 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 subjects

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

6. Subjects who have relatively low bifidobacteria

Key exclusion criteria

1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction

2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily

5. Subjects who are currently taking medications (including herbal medicines) and supplements

6. Subjects who are allergic to medicines and/or the test food related products

7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial

8. Subjects who suffer from COVID-19

9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

10. Subjects who have chronic constipation

11. Subjects who have other diseases that may significantly affect bowel movement, or who have a medical history of them

12. Subjects whose do not have bifidobacteria at Scr

13. Subjects who usually take foods containing rich in lactic acid bacteria, health foods fortified with lactic acid bacteria (such as yogurt and lactic acid bacteria beverages or dietary supplements), or medicines

14. Subjects who usually take medicines, health foods, "Foods for Specified Health Uses," or "Foods with Functional Claims," that may affect bowel movement / take foods fortified with ingredients affecting bowel movement (e.g., fermented foods such as natto, kimchi, and pickles and foods fortified with dietary fiber)

15. Subjects who are judged as ineligible to participate in this study by the physician

Target sample size

20

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

NOF CORPORATION

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 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

2022

Year

10

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

24

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

Completed

Date of protocol fixation

2022

Year

10

Month

19

Day

Date of IRB

2022

Year

10

Month

19

Day

Anticipated trial start date

2022

Year

10

Month

27

Day

Last follow-up date

2023

Year

03

Month

03

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

10

Month

26

Day

Last modified on

2024

Year

04

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056176