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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033978
Receipt No. 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

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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
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
URL(English) https://upload.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


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