UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028734 |
|---|---|
| Receipt number | R000032883 |
| Scientific Title | An evaluation test for alteration of the intestinal environment by test food consumption |
| Date of disclosure of the study information | 2017/08/20 |
| Last modified on | 2020/10/06 09:29:00 |
* 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 test food consumption
Acronym
An evaluation test for alteration of the intestinal environment by test food consumption
Scientific Title
An evaluation test for alteration of the intestinal environment by test food consumption
Scientific Title:Acronym
An evaluation test for alteration of the intestinal environment by test food consumption
Region
| Japan |
Condition
Condition
Healthy women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects for intestinal environment by test food 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 two packages of test food a day for 4 weeks - Washout 4 weeks - Consume two packages of placebo food a day for 4 weeks
Interventions/Control_2
Consume two packages of placebo food a day for 4 weeks - Washout 4 weeks - Consume two packages 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
Female
Key inclusion criteria
(1) Healthy females aged 20 to 59 years old.
(2) 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 take Warfarin.
10) Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver, kidney and heart.
11) Subjects who suspected chronic or serious infectious disease.
12) Females who are pregnant (including the possibility of pregnancy) or are lactating.
13) Subjects who have participated the other clinical test within 1 month before the test start.
14) 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.
15) Subjects who cannot refrain from consumption of medicines and foods which affect intestinal environment during test period.
16) Subjects who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
24
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
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
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Metabologenomics, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Q'SAI 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
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 | 20 | 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 | 21 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032883
