UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017794 |
|---|---|
| Receipt number | R000020616 |
| Scientific Title | Validation study for intestinal functions and anti-inflammatory effect in heathy Japanese adults: a double-blind randomized controlled trial |
| Date of disclosure of the study information | 2015/06/03 |
| Last modified on | 2017/01/30 18:34:56 |
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Basic information
Public title
Validation study for intestinal functions and anti-inflammatory effect in heathy Japanese adults: a double-blind randomized controlled trial
Acronym
Validation study for intestinal functions and anti-inflammatry effect in heathy Japanese adults
Scientific Title
Validation study for intestinal functions and anti-inflammatory effect in heathy Japanese adults: a double-blind randomized controlled trial
Scientific Title:Acronym
Validation study for intestinal functions and anti-inflammatry effect in heathy Japanese adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the effect of "Enterococcus faecalis KH2" on intestinal bacterial flora and inflammation in persons with slight constipation.
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
Key secondary outcomes
CAS-MT
Bristol stool scale
High sensitivity CRP
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
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 1 week
Test food: Enterococcus faecalis KH2 strain supplement
Dose: once a day (1 pack/day)
Usage: ingestion of test food along with the water or hot water after dinner
Interventions/Control_2
Duration: 1 week
Test food: placebo
Dose: once a day (1 pack/day)
Usage: ingestion of test food along with the water or hot water after dinner
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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese adults
2. Defecation (2~5 times/week)
3. Persons who are between 30 and 59 years old
Key exclusion criteria
1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction
2. Currently under treatment for either atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, disease of digestive system (including ulcerative colitis, gastric ulcer, Diverticular Disease of the Colon, etc) or other chronic disease
3. Currently taking medicines, herbal medicines
4. Usually taking yogurt, oligosaccharide or lactic acid bacteria.
5. Allergic to medicines or foods related to the test food of this trial
6. Usually taking supplements and nutrient function foods
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
30
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
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
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO, Inc.
Institute
Department
Personal name
Funding Source
Organization
Specified Nonprofit Corporation The Japanese Association of Clinical Research on Supplements
Organization
Division
Category of Funding Organization
Other
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
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 | 06 | Month | 03 | 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 | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2015 | Year | 08 | Month | 28 | Day |
Date of closure to data entry
| 2015 | Year | 08 | Month | 28 | Day |
Date trial data considered complete
| 2015 | Year | 08 | Month | 28 | Day |
Date analysis concluded
| 2015 | Year | 08 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 03 | 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=R000020616
