UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028733
Receipt No. R000032882
Scientific Title An evaluation test for alteration of the intestinal environment by probiotics consumption
Date of disclosure of the study information 2017/08/18
Last modified on 2020/10/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title An evaluation test for alteration of the intestinal environment by probiotics consumption
Acronym An evaluation test for alteration of the intestinal environment by probiotics consumption
Scientific Title An evaluation test for alteration of the intestinal environment by probiotics consumption
Scientific Title:Acronym An evaluation test for alteration of the intestinal environment by probiotics consumption
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effects for intestinal environment by probiotics consumption.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 16S rRNA gene-based metagenome analysis of gut microbiome and metabolome analysis of intestinal metabolites
Key secondary outcomes * Defecation frequency
* Property of stool
* Volume of stool

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Consume one bottle of test food a day for 4 weeks - Washout 4 weeks - Consume one bottle of placebo food a day for 4 weeks
Interventions/Control_2 Consume one bottle of placebo food a day for 4 weeks - Washout 4 weeks - Consume one bottle of test food a day for 4 weeks
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 (1) Healthy males and females aged 20 to 59 years old. (The ratio of men and women aim to be 1:2)
(2) A half of female subjects aim to be the constipation tendency subjects who defecate 3 to 5 times in a week.
(3) Subjects who do not regularly consume medicines, foods (which affect the intestinal environment) or supplements, during the examination period.
(4) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria (1) Subjects who didn't undergo abdominal surgical operation within 6 month before the test.
(2) Subjects who didn't take antibiotics for 1 week or more within 6 month before the test.
(3) Subjects who have allergy to test food.
(4) Smokers
(5) Subjects who are heavy drinkers of alcohol.
(6) Subjects who are living together (consort or partner etc.) has planned to participate to the same clinical test.
(7) Subjects who plan big change of lifestyle during the test.
(8) Subjects with tendency of chronic diarrhea.
(9) Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver, kidney and heart.
(10) Subjects who suspected chronic or serious infectious disease.
(11) Females who are pregnant (including the possibility of pregnancy) or are lactating.
(12) Subjects who have participated the other clinical test within 1 month before the test.
(13) Subjects who have consumed medicines and/or foods which affect intestinal environment (yogurt, lactic acid bacteria beverage, oligo-sugar, dietary fiber) in the last 2 weeks before the day of preliminary examination.
(14) Subjects who cannot refrain from consumption of medicines and foods which affect intestinal environment during the test.
(15) Subjects who have been determined ineligible by principal investigator or sub-investigator.

Target sample size 36

Research contact person
Name of lead principal investigator
1st name Shinji
Middle name
Last name Fukuda
Organization Metabologenomics, Inc.
Division name Headquarter
Zip code 997-0052
Address C-17,18, 246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL +81-235-64-0330
Email info@metagen.co.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Ichinohe
Organization CPCC Company Limited
Division name Planning & Sales Department
Zip code 101-0047
Address 4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL 03-5297-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

Funding Source
Organization Metabologenomics, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor EZAKI GLICO CO., LTD.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Chiyoda Paramedical Care Clinic
Address 2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel 03-5297-5548
Email IRB@cpcc.co.jp

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
2017 Year 08 Month 18 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 07 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 19 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 18 Day
Last modified on
2020 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032882

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.