UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016463 |
|---|---|
| Receipt number | R000019122 |
| Scientific Title | A randomized double-blind placebo-controlled trial for improving the intestinal environment in human |
| Date of disclosure of the study information | 2015/02/06 |
| Last modified on | 2017/01/30 18:28:14 |
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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 "Powder of the Fermented Extract from Plants EX" 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
Bifidobacterium
Lactobacillales
Bacteroides
Prevotella
Clostridium cluster IV
Clostridium subcluster XIVa
Clostridium cluster XI
Clostridium cluster XVIII
Others
Key secondary outcomes
Subjective symptom
CAS-MT
The faecal form scale
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: 4 weeks
Test material: "Powder of the Fermented Extract from Plants EX" capsules
Dose: One packet (1.2g)/day
Usage: ingestion of test material along with the water just after dinner
Interventions/Control_2
Duration: 4 weeks
Test material: Placebo
Dose: One packet (1.2g)/day
Usage: ingestion of test material along with the water just 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
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
a) Japanese healthy adults who are between 20 and 59 years old.
b) Persons whose stool frequencies are between 2 and 5 times per 7 days
Key exclusion criteria
a) Persons who have previous medical history of malignant tumor or heart failure or myocardial infarction
b) Patients being treated for at least one of following diseases atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension and other chronic disease
c) Persons who take medicines, herbal medicines, or supplement.
d) Persons who are allergic to medicines, or products related to the test material of this trial
e) Persons who habitually take foods that seem to be influential on intestinal environment, e.g., FOSHU, yogurt, and lactic fermenting beverage
f) Persons who smoke
g) Pregnant women, lactating women, or women who want to get pregnant during the trial period
h) Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial
i) Persons who are judged unsuitable to participate in this trial by physician
Target sample size
20
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
25F M&D Tower, Tokyo Medical and Dental University, 1-5-45 Yushima, 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
YAGUMO KOUSAN CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 19 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 22 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 06 | 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=R000019122
