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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Functional dyspepsia(FD) | |
Classification by specialty |
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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 |
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Eligibility | ||||
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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 |
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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 | ||||||
ynaito@koto.kpu-m.ac.jp |
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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 | |||||||
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) |
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Category of Funding Organization | Japanese Governmental office |
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Secondary IDs | NO |
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IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
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Recruitment status | Open public recruiting | ||||||
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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. |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038749 |
Research Plan | |
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Research case data | |
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