UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018958
Receipt number R000021933
Scientific Title A randomized double-blind placebo-controlled trial for improving the intestinal environment in human
Date of disclosure of the study information 2015/09/09
Last modified on 2017/01/30 18:42:23

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Basic information

Public title

A randomized double-blind placebo-controlled trial for improving the intestinal environment in human

Acronym

A trial for improving the intestinal environment in human

Scientific Title

A randomized double-blind placebo-controlled trial for improving the intestinal environment in human

Scientific Title:Acronym

A trial for improving the intestinal environment in human

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of test foods on the intestinal environment in human

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Intestinal bacterial flora (T-RFLP)

Key secondary outcomes

1. Intestinal bacterial flora (real-time PCR)
2. T-regulatory cell (T-reg)
3. The Japanese Version of the Constipation Assessment Scale MT version (CAS-MT)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Period: 4 weeks
Test food: Baker's yeast extract (0.5 g)
Dose: three times a day (0.5 g for once)
Usage: ingestion of the test food along with the water or hot water after each meals

Interventions/Control_2

Period: 4 weeks
Test food: Baker's yeast extract {Baker's yeast extract (0.08 g)+ dextrin (0.42 g)}
Dose: three times a day (0.5 g for once)
Usage: ingestion of the test food along with the water or hot water after each meals

Interventions/Control_3

Period: 4 weeks
Test food: Placebo (dextrin; 0.5 g)
Dose: three times a day (0.5 g for once)
Usage: ingestion of the test food along with the water or hot water after each meals

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese healthy adults
2. The person who has a tendency for the 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 atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, digestive disease (include colonic diverticulosis, ulcerative colitis, Diverticular Disease of the Colon) or other chronic diseases

3. Currently taking medicines, herbal medicines

4. Usually taking Food for Specified Health Uses (FOSHU), Functional Labeling System on health foods, yogurt or lactic acid bacteria beverage, which are related with intestinal regulation.

5. Allergic to medicines or foods related to the test food of this trial

6. Usually taking supplements or nutrient function foods in daily

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

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

9. Judged unsuitable for participating in this trial by physician

Target sample size

24


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

Ministry of Agriculture, Forestry and Fisheries / The agriculture and forestry marine products industry, food industry technology study promotion project

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Seishin-kai Medical Association Inc, Takara Medical Clinic.

Name of secondary funder(s)

ORIENTAL YEAST Co., Ltd.


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 (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)


Other administrative information

Date of disclosure of the study information

2015 Year 09 Month 09 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

2015 Year 09 Month 07 Day

Date of IRB


Anticipated trial start date

2015 Year 09 Month 10 Day

Last follow-up date

2015 Year 12 Month 31 Day

Date of closure to data entry

2015 Year 12 Month 31 Day

Date trial data considered complete

2015 Year 12 Month 31 Day

Date analysis concluded

2015 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 09 Month 09 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=R000021933


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name