UMIN-CTR Clinical Trial

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
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Control
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Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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Purpose of intervention
Type of intervention
Interventions/Control_1
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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

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IRB Contact (For public release)
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Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
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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
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Results
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Baseline Characteristics
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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
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Research case data
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