UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042783
Receipt number R000048835
Scientific Title Effects of consumption of the test food on bowel movement: A randomized double-blind placebo-controlled, parallel-group trial
Date of disclosure of the study information 2020/12/18
Last modified on 2021/07/28 11:19:48

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Basic information

Public title

Effects of consumption of the test food on bowel movement

Acronym

Effects of consumption of the test food on bowel movement

Scientific Title

Effects of consumption of the test food on bowel movement: A randomized double-blind placebo-controlled, parallel-group trial

Scientific Title:Acronym

Effects of consumption of the test food on bowel movement

Region

Japan


Condition

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The measured value of defecation frequency at period VI

Key secondary outcomes

1. The amounts of changes from periods I or II of defecation frequency in period VI

2. The measured values and amounts of changes from periods I or II of defecation frequency in periods III to V

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

4. The measured values of shape and smell of stool and exhilarating feeling in periods III to VI

5. The measured values and amounts of changes from screening (before consumption; Scr) of CAS score of CAS-MT at two and four weeks after consumption (2w, 4w)

6. The measured values of scores for each item of CAS-MT at 2w and 4w

7. The measured values and amounts of changes from Scr of the following items at 4w: total number of bacteria, numbers of lactic acid bacteria, Bifidobacterium, and Clostridium perfringens, salivary immunoglobulin A (s-IgA), scoring of immunological vigor, T lymphocyte age (upper limit), the numbers of T cells, naive T cells, B cells, NK cells, and CD8+CD28+T cells and the ratios of CD4+T cells to CD8+T cells and naive T cells to memory T cells

8. The measured values of the following items at 4w: immunological grade, the scores of T cells, CD8+CD28+T cell ratios, ratio of CD4+T cells to CD8+T cells, naive T cells, ratio of naive T cells to memory T cells, B cells, and NK cells

9. The cumulative number of days with each symptom listed on the diary report (#) and the common cold symptoms (*) during the intervention period per group

10. The cumulative number of days with each symptom listed on the diary report (#) and the common cold symptoms (*), and the maximum duration of the days with common cold symptoms (*) during the intervention period per subject

#: Feverishness, nasal discharge, blocked nose, throat pain, cough, sneezing, whole body malaise, muscle pain, joint pain, chilliness, fatigue, physical condition, and headache
*: The common cold symptom is defined as the onset of any one of #.


Base

Study type

Interventional


Study design

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



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: Four weeks
Test food: Tablets containing high levels of lactic acid bacteria
Administration: Take one tablet per day with water after dinner within 30 minutes

* Daily dose should be taken within the day. If you forget to take the test food or do not have dinner, take it after breakfast of the next day. However, if you forget to take it at the day before examination at 4w, do not take it on the next day.

Interventions/Control_2

Duration: Four weeks
Test food: Tablets containing moderate levels of lactic acid bacteria
Administration: Take one tablet per day with water after dinner within 30 minutes

* Daily dose should be taken within the day. If you forget to take the test food or do not have dinner, take it after breakfast of the next day. However, if you forget to take it at the day before examination at 4w, do not take it on the next day.

Interventions/Control_3

Duration: Four weeks
Test food: Tablets containing low levels of lactic acid bacteria
Administration: Take one tablet per day with water after dinner within 30 minutes

* Daily dose should be taken within the day. If you forget to take the test food or do not have dinner, take it after breakfast of the next day. However, if you forget to take it at the day before examination at 4w, do not take it on the next day.

Interventions/Control_4

Duration: Four weeks
Test food: Tablets without lactic acid bacteria
Administration: Take one tablet per day with water after dinner within 30 minutes

* Daily dose should be taken within the day. If you forget to take the test food or do not have dinner, take it after breakfast of the next day. However, if you forget to take it at the day before examination at 4w, do not take it on the next day.

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Male or female

3. Subjects aged 20 or more

4. Healthy subjects

5. Subjects who defecate three to five times per week

6. Subjects who are aware that they easily feel fatigue and get sick.

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

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

Key exclusion criteria

Subjects (who)

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

2.have a pacemaker or an implantable cardioverter defibrillator

3.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.take "Foods for Specified Health Uses", "Foods with Functional Claims", foods containing viable fungi such as natto, yogurt, and fermented foods, foods fortified with oligosaccharides and dietary fiber, foods containing high amounts of sugar alcohol, food/beverage containing lactic acid bacteria, or other functional food/beverage in daily use and unable to quit the intake during the test period

5.regularly use medicines related to bowel movement, such as intestinal regulator and laxatives

6.currently taking medicines (include herbal medicines) and supplements

7.affected from pollen allergy

8.have received vaccination for infectious diseases such as influenza within a year

9.are smokers, or started smoking cessation within a year

10.drink an excess of alcohol
*weekly average of alcohol intake is more than 60 g/day [Reference materials for the promotion of Health Japan 21 (the second term)]

11.are planning to go abroad or have a job transfer during this trial

12.are allergic to medicines and/or the test food related products. Particularly, lactic acid bacteria, vitamin D, starch, sucrose fatty acid ester, or hydroxypropylmethylcellulose capsule

13.are lactating, pregnant, or intending to become pregnant

14.have been enrolled in other clinical trials within the last 3 months before the invitation to participate in this trial, or plan to participate in another trial during this trial

15.are judged by the principal investigator as ineligible to participate in the trial

Target sample size

80


Research contact person

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 Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.

TEL

03-5793-3623

Email

t-takara@takara-clinic.com


Public contact

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


Sponsor or person

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name



Funding Source

Organization

Fujicco Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)



IRB Contact (For public release)

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

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

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)


Other administrative information

Date of disclosure of the study information

2020 Year 12 Month 18 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

88

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



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 12 Month 11 Day

Date of IRB

2020 Year 12 Month 11 Day

Anticipated trial start date

2020 Year 12 Month 18 Day

Last follow-up date

2021 Year 04 Month 10 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 12 Month 18 Day

Last modified on

2021 Year 07 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048835


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name