UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028606 |
|---|---|
| Receipt number | 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 09:06:34 |
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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
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
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032742
