UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022583
Receipt number R000026027
Scientific Title The verification study for loose stools improvement effect by Bacillus subtilis: a double-blind, randomized placebo-controlled and parallel study
Date of disclosure of the study information 2017/04/01
Last modified on 2017/01/30 18:49:36

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Basic information

Public title

The verification study for loose stools improvement effect by Bacillus subtilis: a double-blind, randomized placebo-controlled and parallel study

Acronym

The verification study for loose stools improvement effect by Bacillus subtilis

Scientific Title

The verification study for loose stools improvement effect by Bacillus subtilis: a double-blind, randomized placebo-controlled and parallel study

Scientific Title:Acronym

The verification study for loose stools improvement effect by Bacillus subtilis

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To validate loose stools improvement by ingestion of Bacillus subtilis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Bristol scale
*1 Perform the test every day.
2. Water content in feces
*2 Perform the test at 0 week and at 4 and 8 weeks after the ingestion
3. Gastrointestinal Symptom Rating Scale (GSRS)
*3 Perform the test at 0 week and at 4 and 8 weeks after the ingestion

Key secondary outcomes

1. Bowel in bacterial flora analysis
*1 Perform the test at 0 week and at 4 and 8 weeks after the ingestion
2. Organic acids
*2 Perform the test at 0 week and at 4 and 8 weeks after the ingestion
3. Decay products
*3 Perform the test at 0 week and at 4 and 8 weeks after the ingestion
4. Short Form-8 (SF-8)
*4 Perform the test at 0 week and 4 and 8 weeks after the ingestion


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 8 weeks
Test material: Tablets containing Bacillus subtilis spores
Dose: Take 3 tablets a day
*2.2X109CFU/day
Administration: Once a day

Interventions/Control_2

Duration: 8 weeks
Test material: placebo
Dose: Take 3 tablets a day
Administration: Once a 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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

1. Healthy Japanese adults

2. Become aware of loose stools

Key exclusion criteria

1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction

2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, Irritable Bowel Syndrome (IBS) or other chronic diseases

3. Currently taking medicines (include herbal medicines), supplements, Food for Specified Health Uses, and/or Foods with Functional Claims
*Particularly taking warfarin

4. Persons who eat natto more than 4 times per week

5. Persons who consume yogurt and/or beverages including lactic acid bacteria/bifidobacteria more than 4 times per week

6. Allergic to medicines or foods related to the test food of this trial.
*Particularly soybeans, natto allergy

7. Pregnant, lactating, or planning to get pregnant during the trial period

8. Persons who have participated by 2015, "Bacillus subtilis, loose stools better effect validation test"

9. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial

10. Judged unsuitable for participating in this trial by physician

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo YAMAMOTO

Organization

ORTHOMEDICO, Inc.

Division name

R&D Department

Zip code


Address

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

TEL

03-3818-0610

Email

kazu@orthomedico.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naoko SUZUKI

Organization

ORTHOMEDICO, Inc.

Division name

R&D Department

Zip code


Address

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

TEL

03-3818-0610

Homepage URL


Email

nao@orthomedico.jp


Sponsor or person

Institute

ORTHOMEDICO, Inc.

Institute

Department

Personal name



Funding Source

Organization

ASAHI CALPIS WELLNESS CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Seishin-kai Medical Association Inc, Takara Medical Clinic.

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Other administrative information

Date of disclosure of the study information

2017 Year 04 Month 01 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


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

2016 Year 05 Month 30 Day

Date of IRB


Anticipated trial start date

2016 Year 06 Month 03 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 06 Month 02 Day

Last modified on

2017 Year 01 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026027


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name