UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034001
Receipt number R000038764
Scientific Title Enterobacterial analysis as the biomarker for the inflammatory bowel disease
Date of disclosure of the study information 2018/09/03
Last modified on 2019/03/31 15:20:49

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Basic information

Public title

Enterobacterial analysis as the biomarker for the inflammatory bowel disease

Acronym

Enterobacterial analysis as the biomarker for the inflammatory bowel disease

Scientific Title

Enterobacterial analysis as the biomarker for the inflammatory bowel disease

Scientific Title:Acronym

Enterobacterial analysis as the biomarker for the inflammatory bowel disease

Region

Japan


Condition

Condition

Inflammatory bowel disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

It is noninvasive and is established the biomarker with a little patient's share of medical expenses

Basic objectives2

Others

Basic objectives -Others

identify the entrobacteria

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We compare laboratory data, clinical conditions and endoscopic findings one-year after entry with patient' enterobacteria, and we identify the enterobacteria which correlate with clinical conditions and endoscopic findings.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Collection the fecal samples

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

IBD patients
More than 20 years old

Key exclusion criteria

1. Patients with severe situation
2. patients with pregnancy
3. Patients taking anticoagulant.
4. Patient who doctors realize inappropriate for this study.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Dai
Middle name
Last name Ishikawa

Organization

Juntendo University

Division name

Gastroenterology

Zip code

113-8421

Address

bunkyo-ku hongo 2-1-1

TEL

0338133111

Email

Dai@juntendo.ac.jp


Public contact

Name of contact person

1st name Koki
Middle name
Last name Okahara

Organization

Juntendo University

Division name

Gastroenterology

Zip code

113-8421

Address

bunkyo-ku hongo 2-1-1

TEL

0338133111

Homepage URL


Email

k-okahara@juntendo.ac.jp


Sponsor or person

Institute

Juntendo Universuty

Institute

Department

Personal name



Funding Source

Organization

none

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

Juntendo university hospital

Address

2-1-1 Hongo Bunkyoku

Tel

0338133111

Email

kenkyu5858@juntendo.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

2018 Year 09 Month 03 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 09 Month 22 Day

Date of IRB

2017 Year 09 Month 22 Day

Anticipated trial start date

2017 Year 09 Month 22 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 03 Day

Last modified on

2019 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038764


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name