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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028606
Receipt No. R000032742
Scientific Title The verification study for improving the intestinal environment: A randomized open-label parallel-group study
Date of disclosure of the study information 2017/08/17
Last modified on 2018/02/07

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Basic information
Public title The verification study for improving the intestinal environment: A randomized open-label parallel-group study
Acronym The verification study for improving the intestinal environment
Scientific Title The verification study for improving the intestinal environment: A randomized open-label parallel-group study
Scientific Title:Acronym The verification study for improving the intestinal environment
Region
Japan

Condition
Condition Healthy Japanese adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effects of the test food on improving intestinal environment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. The Japanese version of Constipation Assessment Scale MT version (CAS-MT)

* Assess at screening and examination before consuming, and at 1, 2, 3, and 4 weeks after consuming
Key secondary outcomes 1. Bacterial flora analysis (Terminal Restriction Fragment Length Polymorphism; T-RFLP)

2. Subjective symptoms
a. Bowel movement diary
b. Bristol scale

*1 Assess at 0 and 4 weeks after consuming
*2 Record the diary from a week before consuming to the day before 4 weeks after consuming

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
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 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 4 weeks
Test materials: Fermented plant extracts
Dose: 3 packs per day (2 g x 3)
Administration: Take 1 pack of the test food after breakfast, lunch, and dinner.
*If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2 Duration: 4 weeks
Test materials: Fermented plant extracts
Dose: 1 pack (2 g) per day
Administration: Take 1 pack of the test food after breakfast.
*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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
50 years-old >
Gender Female
Key inclusion criteria 1. Healthy Japanese females

2. Subjects who defecate two to five times per week

3. Subjects who are judged as eligible to participate in the study by the principal investigator

4. Subjects who have relatively high CAS score in the Japanese version of CAS-MT at screening and examination before consuming
Key exclusion criteria 1. At least one previous medical history or under the treatment 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 or other chronic diseases

3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", food/beverage including lactic acid bacteria, or other functional food/beverage in daily

4. Currently taking medicines (include herbal medicines) and supplements

5. Subjects who are allergic to medicines and/or the test food related products

6. Subjects who are allergic to latex

7. Subjects who are pregnant, breast-feeding, and plan to become a pregnant

8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial

9. Subjects who are judged as ineligible to participate in the study by the principal investigator
Target sample size 14

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo YAMAMOTO
Organization ORTHOMEDICO Inc.
Division name CEO
Zip code
Address 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
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, Japan.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization Functional Food Creation Research Institute Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Medical Corporation Seishinkai, Takara 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 (東京都)
Medical Corporation Seishinkai, Takara Medical Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 17 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
2017 Year 08 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 18 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
2017 Year 08 Month 09 Day
Last modified on
2018 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032742

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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