UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028459
Receipt No. 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 2018/03/07

* 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 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
Middle name
Last name Shinji Fukuda
Organization Metabologenomics, Inc.
Division name Headquarters
Zip code
Address C-17,18, 246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL +81-235-64-0330
Email research@metagen.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinnosuke Murakami
Organization Metabologenomics, Inc.
Division name Headquarters
Zip code
Address C-17,18, 246-2 Mizukami, Kakuganji, Tsuruoka, Yamagata, Japan
TEL +81-235-64-0330
Homepage URL
Email research@metagen.co.jp

Sponsor
Institute Metabologenomics, Inc.
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
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
2018 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.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


Contact us.