UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033978
Receipt number R000038749
Scientific Title analysis of endoscopic brush samples identified mucosa associated dysbiosis and the expression of tight junction protein in functional dyspepsia.
Date of disclosure of the study information 2018/09/10
Last modified on 2018/08/31 21:40:18

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Basic information

Public title

analysis of endoscopic brush samples identified mucosa associated dysbiosis and the expression of tight junction protein in functional dyspepsia.

Acronym

mucosa associated dysbiosis and the expression of tight junction protein in functional dyspepsia.

Scientific Title

analysis of endoscopic brush samples identified mucosa associated dysbiosis and the expression of tight junction protein in functional dyspepsia.

Scientific Title:Acronym

mucosa associated dysbiosis and the expression of tight junction protein in functional dyspepsia.

Region

Japan


Condition

Condition

Functional dyspepsia(FD)

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this present study was to clarify 1) the relationship between upper gastrointestinal symptoms in FD and the characteristics of the gastrointestinal MAM, from the oral cavity to the descending portion of duodenum by using 16S-rRNA V3-V4 gene sequences. 2) the targeting gut dysbiosis MAM to exacerbate symptoms in patients with FD by using some questionnaires.

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The characteristics of the gastrointestinal MAM in FD.

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

criteria of Rome4 in FD without infection of Hericobater pyroli

Key exclusion criteria

Additional exclusion criteria were as follows: administration of antibiotics, corticosteroids, immunosuppressants, and acid suppressing agents proton pump inhibitors (PPIs) and histamine-type 2 receptor blockers (H2 blockers) within the past 1 month, and a history of underlying malignant diseases.Patients with other factors that could affect intestinal motility or gut microbiota, as evaluated by researchers, were also ineligible.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuji Naito

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Molecular Gastroenterology and Hepatology

Zip code


Address

465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan

TEL

0752515519

Email

ynaito@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akifumi Fukui

Organization

North Medical Center Kyoto Prefectural University of Medicine

Division name

Department of Molecular Gastroenterology and Hepatology

Zip code


Address

481,Otokoyama, Yosano-cho, Yosano-gun, Kyoto 629-2261, Japan

TEL

0772463371

Homepage URL


Email

afukui@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science through a grant, Grants-in-Aid for Scientific Research (KAKENHI) (C) to Akifumi Fukui (No. 17K09358)

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2018 Year 09 Month 10 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 05 Month 22 Day

Date of IRB


Anticipated trial start date

2017 Year 05 Month 22 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Eleven FD patients and seven healthy volunteers subject without gastrointestinal mucosal inflammation or carcinoma or using antibiotics and acid suppressing agents within one month were enrolled.mucosa samples from the 2nd portion of duodenum were collected with a brush under endoscopic examination. MAM profiles of each sample were analyzed by 16S-rRNA V3-V4 gene sequences.


Management information

Registered date

2018 Year 08 Month 31 Day

Last modified on

2018 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038749


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name