UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039223 |
|---|---|
| Receipt number | R000044679 |
| Scientific Title | Analysis of the gut microbial metabolites and microbiome in the blood, urine, feces from healthy individuals |
| Date of disclosure of the study information | 2020/01/22 |
| Last modified on | 2020/01/22 16:58:03 |
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Basic information
Public title
Analysis of the gut microbial metabolites and microbiome in the blood, urine, feces from healthy individuals
Acronym
Analysis of the gut microbial metabolites and microbiome in healthy individuals
Scientific Title
Analysis of the gut microbial metabolites and microbiome in the blood, urine, feces from healthy individuals
Scientific Title:Acronym
Analysis of the gut microbial metabolites and microbiome in healthy individuals
Region
| Japan |
Condition
Condition
Allergic diseases, metabolic related diseases
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to investigate the relationship between amino acid enantiomers in body fluids and gut microbiome
Basic objectives2
Others
Basic objectives -Others
Quantification of amino acid enantiomers in the blood, urine, and feces.
Fecal microbiome.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The concentration of D-/L-amino acids in human serum, urine and feces.
Metagenomics for human feces
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The volunteers who are 20-45 years old in Shinanomachi campus of Keio University
Key exclusion criteria
Individuals who take any kinds of antibiotics within 3 weeks before the sample collection or eat breakfast on the sampling day are excluded from our study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Junpei |
| Middle name | |
| Last name | Sasabe |
Organization
Keio University School of Medicine
Division name
Department of Pharmacology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo,
TEL
0353633751
sasabe@a8.keio.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Gonda |
Organization
Department of Pharmacology, Keio University School of Medicine
Division name
Department of Pharmacology, Keio University School of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo,
TEL
0353633751
Homepage URL
ygonda@keio.jp
Sponsor or person
Institute
Department of Pharmacology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shseido company
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio university school of medicine
Address
35 Shinanomachi, Shinjuku, Tokyo,
Tel
0333531211
med-rinri-jimu@adst.keio.ac.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
| 2020 | Year | 01 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation study (non-intervention study)
Recruitment period: 2020/01-2020/03
Reward per participant: 3000 yen
We recruit the participants from adults (20-45 years old) at the Shinanomachi campus, Keio university.
We inform participants about our clinical study and get consent from them prior to sampling. Only the participants who agree with this study are given the container to collect their urine and stool. And they should bring their urine and stool samples on the blood collection day.
Urine sample (4ml) should be collected from the first urination in the morning and stool sample(3g) within 24 hours before or after the blood collection day. Blood samples (2ml) are drawn from their antecubital vein to EDTA tubes. Then plasma is separated by spinning.
Enantiomers of amino acids in the plasma, urine, and stool were analyzed using a two-dimensional HPLC system. Fecal microbiota will be assessed with 16S rRNA gene sequencing.
Management information
Registered date
| 2020 | Year | 01 | Month | 22 | Day |
Last modified on
| 2020 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044679
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