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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000017794 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Healthy adults | |
Classification by specialty |
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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 |
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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 |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | ORTHOMEDICO, Inc. |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020616 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |