UMIN-CTR Clinical Trial

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

Effects of consumption of the test food on the intestinal environment and bowel movement 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 intestinal environment and bowel movement 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 measured value of defecation frequency in period 3*

* Period 3: 8~14 days after consumption

Key secondary outcomes

1. The measured value of numbers of butyrate-producing bacteria (Clostridium butyricum) at two weeks after consumption (2w)

2. The amount of change from screening (before consumption; Scr) of numbers of butyrate-producing bacteria (Clostridium butyricum) at 2w

3. The defecation frequency in period 2*

4. The defecation days and amount of defecation in period 2 and 3*

5. The stool shape, stool smell, and exhilarating feeling of defecation in period 2 and 3*

6. The score of the Japanese Version of the Constipation Assessment Scale [middle term] (CAS-MT) at 2w

7. Each item of CAS-MT at 2w

8. The occupancy rate of bacteria in the stool and the diversity index (Chao1, Shannon, ACE, Jackknife, NPShannon, Simpson, Phylogenetic Diversity) at 2w

9. Short-chain fatty acid levels (acetic acid, propionic acid, and butyric acid) in the stool

10. Short-chain fatty acid levels (acetic acid, propionic acid, and butyric acid) in the blood

* Period 1: The seven days prior to Scr
Period 2: The seven days after initial consumption
Period 3: 8~14 days after consumption

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

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: Two weeks
Test food: Capsule containing butyrate-producing bacteria
Administration: Take three capsules per day with water

*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: Two weeks
Test food: Placebo capsule
Administration: Take three capsules per day with water

*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 whose defecation frequency is few in seven days prior to Scr

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, rheumatoid arthritis, 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"

5. Subjects who take foods or medicines containing butyrate-producing bacteria (Clostridium butyricum)

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

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

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

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 are judged inappropriate as participants from answers to lifestyle questionnaires

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

Target sample size

68

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

Noster Inc.

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 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

2023

Year

10

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

76

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

2023

Year

09

Month

20

Day

Date of IRB

2023

Year

09

Month

20

Day

Anticipated trial start date

2023

Year

10

Month

21

Day

Last follow-up date

2024

Year

02

Month

25

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

10

Month

20

Day

Last modified on

2024

Year

07

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059969