UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047278 |
|---|---|
| Receipt number | R000053916 |
| Scientific Title | Features of Gut Prokaryotic Virome in Japanese Patients with Inflammatory bowel disease |
| Date of disclosure of the study information | 2022/03/24 |
| Last modified on | 2025/04/10 18:16:03 |
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Basic information
Public title
Features of Gut Virome in Japanese Patients with Inflammatory bowel disease
Acronym
Gut Virome
Scientific Title
Features of Gut Prokaryotic Virome in Japanese Patients with Inflammatory bowel disease
Scientific Title:Acronym
Gut Prokaryotic Virome
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the composition of intestinal phage and bacterial flora in patients with inflammatory bowel disease.
Basic objectives2
Others
Basic objectives -Others
To examine whether there are abnormalities in the composition of intestinal phage in IBD.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of the intestinal virome
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Ulcerative colitis
Crohn's disease
healthy control
over 20 years old
Persons who can obtain the information in writing from the individual.
Key exclusion criteria
Persons with colorectal cancer
Those who are taking anticoagulants.
Persons who are unable to give their consent
Persons who are judged to be unsuitable as examinees by the principal investigator .
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Ohno |
Organization
Shiga University of Medical Science
Division name
Gastroenterology and Hematology
Zip code
520-2192
Address
Seta-Tsukinowa Otsu
TEL
0775482217
hqmed2@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Imai |
Organization
Shiga University of Medical Science
Division name
Gastroenterology and Hematology
Zip code
520-2192
Address
Seta-Tsukinowa Otsu
TEL
0775482217
Homepage URL
timai@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Shiga University of Medical Science
Address
Seta-Tsukinowa Otsu
Tel
0775483576
hqrec@belle.shiga-med.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 | 03 | Month | 24 | 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
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 07 | 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
| 2022 | Year | 03 | Month | 24 | Day |
Last modified on
| 2025 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053916
