UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040192
Receipt number R000045806
Scientific Title Association of gut microbiota with inflammation, cancer, or dysfunction in gastrointestinal diseases
Date of disclosure of the study information 2020/04/18
Last modified on 2020/04/18 16:18:41

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Basic information

Public title

Association of gut microbiota with inflammation, cancer, or dysfunction in gastrointestinal diseases

Acronym

Association between gut microbiota and gastrointestinal diseases

Scientific Title

Association of gut microbiota with inflammation, cancer, or dysfunction in gastrointestinal diseases

Scientific Title:Acronym

Association between gut microbiota and gastrointestinal diseases

Region

Japan


Condition

Condition

Gastrointestinal disease associated with inflammation, cancer, or dysfunction

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the association of human indigenous microbiota (e.g., saliva, gastric fluid, bile, stool, urine, sweat) with the pathophysiology of gastrointestinal diseases associated with inflammation, cancer, or dysfunction.

Basic objectives2

Others

Basic objectives -Others

Clarifying pathophysiology

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relative abundance of microbiota in 16S rRNA sequencing

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who have (or are suspected to have) a gastrointestinal disease with inflammation, cancer, or dysfunction

Key exclusion criteria

Patients whom the attending physician recognized as not suitable for this study because he / she did not have the ability to judge whether or not to participate in this study

Target sample size

1250


Research contact person

Name of lead principal investigator

1st name Hiroto
Middle name
Last name Furuhashi

Organization

The Jikei University School of Medicine

Division name

Department of Endoscopy

Zip code

1058471

Address

3-19-18, Nishi-Shimbashi, Minato-ku, Tokyo

TEL

03-3433-1111

Email

ms04furuhashi@jikei.ac.jp


Public contact

Name of contact person

1st name Hiroto
Middle name
Last name Furuhashi

Organization

The Jikei University School of Medicine

Division name

Department of Endoscopy

Zip code

1058471

Address

3-19-18, Nishi-Shimbashi, Minato-ku, Tokyo

TEL

03-3433-1111

Homepage URL


Email

ms04furuhashi@jikei.ac.jp


Sponsor or person

Institute

The Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

The Jikei University School of Medicine

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

Institutional Review Board of The Jikei University School of Medicine

Address

3-19-18, Nishi-Shimbashi, Minato-ku, Tokyo

Tel

0334331111

Email

rinri@jikei.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 04 Month 18 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

Enrolling by invitation

Date of protocol fixation

2019 Year 09 Month 02 Day

Date of IRB

2019 Year 09 Month 02 Day

Anticipated trial start date

2019 Year 09 Month 02 Day

Last follow-up date

2024 Year 09 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Human gastrointestinal fluid spontaneously excreted or aspirated with an endoscope are analyzed using meta 16S rRNA sequencing, shotgun sequencing, metatranscriptome analysis, or metabolome analysis. Then, the relationship between sequence data and clinical severity scores is statistically analyzed.


Management information

Registered date

2020 Year 04 Month 18 Day

Last modified on

2020 Year 04 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045806


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name