UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028459 |
|---|---|
| Receipt number | R000032583 |
| Scientific Title | Verification of long term changing of intestinal environment in same individual |
| Date of disclosure of the study information | 2017/09/20 |
| Last modified on | 2023/10/11 13:05:01 |
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Basic information
Public title
Verification of long term changing of intestinal environment in same individual
Acronym
Verification of long term changing of intestinal environment in same individual
Scientific Title
Verification of long term changing of intestinal environment in same individual
Scientific Title:Acronym
Verification of long term changing of intestinal environment in same individual
Region
| Japan |
Condition
Condition
Men and women
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify long term changing of intestinal environment in same Japanese individual.
Basic objectives2
Others
Basic objectives -Others
Research
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
16S rRNA gene-based metagenome analysis of gut microbiome and metabolome analysis of intestinal metabolites
Key secondary outcomes
* Defecation frequency and stool volume
* Stool property such as color, shape and odor. Feeling after defecation. Abdominal discomfort.
* Number of living bacteria in fecal samples measured by using selective media.
* Preclinical verification of preventive and/or therapeutic effects by administration of fecal samples and/or bacteria that are isolated from fecal samples, using experimental animals.
* Analysis of gene function of intestinal microbiota by metagenome analysis.
* 16S rRNA gene-based metagenome analysis of oral, skin and urine.
* Metabolome analysis of saliva and urine.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Males and females aged 0 to 100 years old.
(2) Subjects who don't regularly use specific medicines.
(3) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study. In case of minor and person who don't have ability to agree, the agreement by substitute person is necessary.
Key exclusion criteria
(1) Subjects who have current medical history of severe disease.
(2) Subjects who have been determined ineligible by principal investigator.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Fukuda |
Organization
Metabologenomics, Inc.
Division name
Headquarters
Zip code
9970052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
research@metagen.co.jp
Public contact
Name of contact person
| 1st name | Shinnosuke |
| Middle name | |
| Last name | Murakami |
Organization
Metabologenomics, Inc.
Division name
Headquarters
Zip code
9970052
Address
246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL
+81-235-64-0330
Homepage URL
research@metagen.co.jp
Sponsor or person
Institute
Metabologenomics, Inc.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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 | 09 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Research
Subjects recruitment method: Subjects will be selected from applicants according to selection criteria and exclusion criteria, and in consideration of the balance of their age and sex.
Measurement items:
16S rRNA gene-based metagenome analysis and metabolome analysis of fecal samples.
Management information
Registered date
| 2017 | Year | 07 | Month | 31 | Day |
Last modified on
| 2023 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032583
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
