UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047827 |
|---|---|
| Receipt number | R000054525 |
| Scientific Title | Studies on the influence of duodenal and small intestinal microbiota and bile acids on the pathogenesis of liver diseases |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2022/05/22 12:36:52 |
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Basic information
Public title
Studies on the influence of duodenal and small intestinal microbiota and bile acids on the pathogenesis of liver diseases
Acronym
Studies on the influence of duodenal and small intestinal microbiota and bile acids on the pathogenesis of liver diseases
Scientific Title
Studies on the influence of duodenal and small intestinal microbiota and bile acids on the pathogenesis of liver diseases
Scientific Title:Acronym
Studies on the influence of duodenal and small intestinal microbiota and bile acids on the pathogenesis of liver diseases
Region
| Japan |
Condition
Condition
non-alcoholic fatty liver disease(NAFLD)
metabolic associated fatty liver disease(MAFLD)
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To identify changes in small intestinal gut microbiota in non-alcoholic fatty liver disease/metabolic associated fatty liver disease.
Basic objectives2
Others
Basic objectives -Others
To identify metabolic and functional changes in the small intestinal microbiota in non-alcoholic fatty liver disease/metabolic associated fatty liver disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of diversity and characteristic species of small intestinal microbiota in non-alcoholic fatty liver disease/metabolic associated fatty liver disease
Key secondary outcomes
Identification of metabolic dysfunctions of the small intestinal microbiota in non-alcoholic fatty liver disease/metabolic associated fatty liver disease
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Liver disease patients (priority to non-alcoholic fatty liver disease and metabolic associated fatty liver disease) .
Patients with non-liver disease scheduled for endoscopy.
Key exclusion criteria
Patients who do not agree with the study.
Patients who cannot understand the explanation of the study.
Patients who cannot underdo endoscopy due to their general condition.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Niida |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
791-0295
Address
Shitsukawa, Toon City, Ehime, Japan
TEL
089-960-5308
3naika@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Niida |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
791-0295
Address
Shitsukawa, Toon City, Ehime, Japan
TEL
089-960-5308
Homepage URL
3naika@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Ehime University
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
Ethics Committee of Ehime University Hospital
Address
Shitsukawa, Toon City, Ehime, Japan
Tel
+81899605914
rinri@m.ehime-u.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
| 2022 | Year | 06 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients with non-alcoholic fatty liver disease/metabolic associated fatty liver disease and non-liver disease who underwent upper endoscopy at our hospital between June 2022 and June 2024 who meet the selection criteria will be included. The endpoints will be the mucosa-associated intestinal microbiota and metabolites in the intestinal fluid in the horizontal duodenal leg, and a cross-sectional study will be conducted. Intestinal flora are sampled from the horizontal duodenal leg using brush forceps during upper endoscopy, and intestinal fluid is collected using a suction tube. Shotgun metagenomic analysis will be performed on the mucosal and fecal specimens collected. Metabolites in intestinal fluid will also be analyzed.
Management information
Registered date
| 2022 | Year | 05 | Month | 22 | Day |
Last modified on
| 2022 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054525
