UMIN-CTR Clinical Trial

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