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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018958
Receipt No. 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

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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
Institute ORTHOMEDICO, Inc.
Institute
Department

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
URL(English) https://upload.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


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