UMIN-CTR Clinical Trial

Basic information
Public title	Prospective sampling, multicenter study investigating the relationship between background data and the intestinal environment in patients with diverticulosis and non-diverticulosis
Acronym	Survey of intestinal environment in patients with diverticulosis
Scientific Title	Prospective sampling, multicenter study investigating the relationship between background data and the intestinal environment in patients with diverticulosis and non-diverticulosis
Scientific Title:Acronym	Survey of intestinal environment in patients with diverticulosis
Region	Japan

Condition
Condition	Patients with colonic diverticulosis and non-diverticulosis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare fecal bile acid concentrations and short-chain fatty acids in diverticulum patients and non-diverticulum patients
Basic objectives2	Others
Basic objectives -Others	To investigate the relationship between the causes and symptoms of diverticulosis and Intestinal environment
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fecal bile acid concentration
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Subjects whose age at registration is 20 to 85 years old (2) Subjects with medical records (3) Subjects for whom consent is obtained in writing regarding participation in this study (4) Subjects who have undergone abdominal computed tomography (CT) or lower gastrointestinal endoscopy (CF) within 3 years from the date of consent acquisition and have been diagnosed with the presence or absence of a diverticulosis.
Key exclusion criteria	(1) Subjects who cannot collect samples due to defecation disorders (2) Other subjects who were judged to be inappropriate as subjects by the judgment of the doctor
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name michihiro Middle name Last name iwaki
Organization	Yokohama City University School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	2360004
Address	Yokohamashi Kanazawaku Fukuura 3-9
TEL	0457872800
Email	michihirokeidai@yahoo.co.jp

Public contact
Name of contact person	1st name yuki Middle name Last name kasai
Organization	Yokohama City University School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	2360004
Address	Yokohamashi Kanazawaku Fukuura 3-9
TEL	0457872800
Homepage URL
Email	y.kasai.91@gmail.com

Sponsor
Institute	Yokohama City University School of Medicine
Institute
Department

Funding Source
Organization	Yokohama City University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Public University Corporation Yokohama City University Hospital Clinical Trial Review Committee
Address	Yokohamashi Kanazawaku Fukuura 3-9
Tel	0457872714
Email	chiken@yokohama-cu.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	2020 Year 12 Month 11 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	2020 Year 12 Month 01 Day
Date of IRB	2020 Year 10 Month 15 Day
Anticipated trial start date	2020 Year 12 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	Stools will be collected from subjects who meet the selection criteria and analyzed in detail. At the same time, the abdominal symptoms will be evaluated and the relationship will be examined.

Management information
Registered date	2020 Year 12 Month 10 Day
Last modified on	2020 Year 12 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048745