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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016463
Receipt No. 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

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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
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.
TEL 03-3818-0610
Homepage URL
Email nao@orthomedico.jp

Sponsor
Institute ORTHOMEDICO Inc.
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019122

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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