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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039223
Receipt No. 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

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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
Email 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
Email ygonda@keio.jp

Sponsor
Institute Department of Pharmacology, Keio University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044679

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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