UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043262 |
|---|---|
| Receipt number | R000049378 |
| Scientific Title | Prospective sampling, multicentre study to investigate the association between background data and the intestinal environment in patients with diverticulosis of the colon and non-diverticulosis (healthy subjects and patients with chronic intestinal pseudo-obstruction, constipation or diarrhoea etc). |
| Date of disclosure of the study information | 2021/02/05 |
| Last modified on | 2024/12/31 11:14:10 |
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Basic information
Public title
Prospective sampling, multicentre study to investigate the association between background data and the intestinal environment in patients with diverticulosis of the colon and non-diverticulosis (healthy subjects and patients with chronic intestinal pseudo-obstruction, constipation or diarrhoea etc).
Acronym
Study to investigate the association between background data and the intestinal environment in patients with diverticulosis of the colon and non-diverticulosis (healthy subjects and patients with chronic intestinal pseudo-obstruction, constipation or diarrhoea etc).
Scientific Title
Prospective sampling, multicentre study to investigate the association between background data and the intestinal environment in patients with diverticulosis of the colon and non-diverticulosis (healthy subjects and patients with chronic intestinal pseudo-obstruction, constipation or diarrhoea etc).
Scientific Title:Acronym
Study to investigate the association between background data and the intestinal environment in patients with diverticulosis of the colon and non-diverticulosis (healthy subjects and patients with chronic intestinal pseudo-obstruction, constipation or diarrhoea etc).
Region
| Japan |
Condition
Condition
Patients with diverticula, those without diverticula (healthy individuals or those with chronic intestinal pseudo-obstruction, diarrhoea, constipation, etc.)
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the causal relationship between background data and the intestinal environment in patients with and without diverticula (healthy subjects or patients with chronic intestinal pseudo obstruction, constipation or diarrhoea etc).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total bile acid concentration in stool
Key secondary outcomes
Stool metabolites, stool markers, gut microbiota, blood metabolites, blood markers, QOL (e.g. SF-36), QOL/questionnaire (NRS, PAC-QOL, PAC-SYM, GSRS, etc.), frequency of each disease, risk factors.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) 20 years old or older at the time of registration
(2) Gender is not required
(3) Patients with a medical record
(4) Patients who can provide written consent for participation in this study
Key exclusion criteria
(1) Patients who cannot collect specimens due to defecation disorder
(2) Other patients who are judged by the physician to be unsuitable for the study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Takaomi |
| Middle name | |
| Last name | Kessoku |
Organization
Yokohama city university hospital
Division name
Palliative Medicine
Zip code
236-0805
Address
3-9, Fukuura, Kanazawa-ku, Yokohama city
TEL
045-787-2640
kessoku-tho@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Ujiie |
Organization
Yokohama city university
Division name
Gastroenterology and hepatology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama city
TEL
0457872640
Homepage URL
kessoku-tho@umin.ac.jp
Sponsor or person
Institute
Yokohama city university
Institute
Department
Personal name
Funding Source
Organization
Yokohama city university
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
Yokohama city university
Address
3-9, Fukuura, Kanazawa-ku, Yokohama city
Tel
0457872640
kessoku-tho@umin.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
| 2021 | Year | 02 | Month | 05 | 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 | 10 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 02 | Month | 05 | Day |
Last modified on
| 2024 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049378
