UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042710 |
|---|---|
| Receipt number | R000048745 |
| Scientific Title | Prospective sampling, multicenter study investigating the relationship between background data and the intestinal environment in patients with diverticulosis and non-diverticulosis |
| Date of disclosure of the study information | 2020/12/11 |
| Last modified on | 2020/12/10 13:27:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
y.kasai.91@gmail.com
Sponsor or person
Institute
Yokohama City University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048745
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
