UMIN-CTR Clinical Trial

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
Email	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
Email	3naika@m.ehime-u.ac.jp

Sponsor
Institute	Ehime University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054525