UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food on bowel movement and intestinal environment

Acronym

Effects of consumption of the test food on bowel movement and intestinal environment

Scientific Title

Effects of consumption of the test food on bowel movement and intestinal environment: a randomized, double-blind, placebo-controlled trial

Scientific Title:Acronym

Effects of consumption of the test food on bowel movement and intestinal environment

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 bowel movement and intestinal environment in healthy Japanese women aged 30 or more and less than 50

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The measured value of defecation frequency at period V*

Key secondary outcomes

1. The amounts of changes from periods I* of defecation frequency in period V*

2. The measured values and amounts of changes from periods I* of defecation frequency in periods II to IV*

3. The measured values and amounts of changes from periods I* of defecation days and amount of defecation in periods II to V*

4. The percentages of shape and smell of stool and exhilarating feeling in periods II to V*

5. The measured values and amounts of changes from screening (before consumption; Scr) of CAS score of CAS-MT at four weeks after consumption (4w)

6. The measured values of scores for each item of CAS-MT at 4w

7. The measured values and amounts of changes from Scr of intestinal flora (Bifidobacterium, Lactobacillales, Bacteroides, Prevotella, Clostridium cluster IV, Clostridium cluster IX, Clostridium cluster XI, Clostridium subcluster XIVa, Clostridium cluster XVIII, Others) at 4w

* Periods I~V are designed as below: period I, the seven days prior the Scr; period II, the seven days after initial consumption; period III, 8~14 days after consumption; period IV, 15~21 days after consumption; period V, 22 days after consumption to the day before 4w

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: Four weeks
Test food: Food containing S. boulardii
Administration: Take two capsules per day after breakfast with water

* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_2

Duration: Four weeks
Test food: Placebo food
Administration: Take two capsules per day after breakfast with water

* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the 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

30

years-old

<=

Age-upper limit

50

years-old

>

Gender

Female

Key inclusion criteria

1. Japanese

2. Female

3. Subjects aged 30 or more and less than 50

4. Healthy subjects

5. Subjects who defecate three to five times per week

6. Subjects who are judged as eligible to participate in the study by the physician

7. Subjects who have relatively few defecation frequency during a week before Scr

8. Subjects whose the occupancy rate of Bifidobacterium or Lactobacillales at stool test of Scr is not 0%

Key exclusion criteria

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

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

3. Subjects who currently undergoing treatment for any of the following chronic disease: 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", "Foods with Functional Claims", or other functional food/beverage in daily

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

6. Subjects allergic to medications and/or the test-food-related products (especially yeast)

7. Subjects who are pregnant, lactation, or planning to become pregnant

8. 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

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

Target sample size

40

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

KINS Co., Ltd.

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

2021

Year

06

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

44

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

2021

Year

06

Month

16

Day

Date of IRB

2021

Year

06

Month

16

Day

Anticipated trial start date

2021

Year

06

Month

23

Day

Last follow-up date

2021

Year

11

Month

21

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

06

Month

22

Day

Last modified on

2024

Year

04

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050966