UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055410 |
|---|---|
| Receipt number | R000063310 |
| Scientific Title | Characterization of the gut virome of Japanese patients with ulcerative colitis in endoscopic remission |
| Date of disclosure of the study information | 2024/09/05 |
| Last modified on | 2024/09/04 04:39:25 |
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Basic information
Public title
Characterization of the gut virome of Japanese patients with ulcerative colitis in endoscopic remission
Acronym
The gut virome of UC patients
Scientific Title
Characterization of the gut virome of Japanese patients with ulcerative colitis in endoscopic remission
Scientific Title:Acronym
The gut virome of UC patients
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ulcerative colitis (UC) is a refractory inflammatory bowel disease (IBD) believed to be a multifactorial disorder arising from genetic predispositions combined with environmental factors, leading to abnormalities in the gut microbiota and immune system. Numerous studies have explored the relationship between the gut microbiota, particularly the bacterial components, and UC, revealing a characteristic increase in Proteobacteria and a decrease in Firmicutes. Despite the fact that viruses are estimated to outnumber bacteria by tenfold in the gut, the role of viruses in UC has been less thoroughly investigated. The gut virome consists of both prokaryotic and eukaryotic viruses, with prokaryotic viruses comprising approximately 90% of the total. Bacteriophages (phages), which infect prokaryotes (bacteria and archaea), are classified into virulent (lytic) phages and temperate (lysogenic) phages based on their life cycle. Virulent phages replicate within and subsequently lyse the host bacterial cell to release viral particles, whereas temperate phages integrate their genetic material into the host chromosome, replicating along with the host under normal conditions and switching to the lytic cycle under specific conditions such as external stress. In this study, we aim to investigate the gut virome of Japanese UC patients, a population that has not been thoroughly studied, to elucidate its characteristics.
Basic objectives2
Others
Basic objectives -Others
This study is an observational study aimed at elucidating the characteristics of the gut virome in patients with ulcerative colitis in endoscopic remission compared to healthy individuals.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes are the comparison of phage diversity, relative abundance, and their correlation with host factors between healthy individuals and patients with ulcerative colitis in remission.
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
1. Patients Diagnosed with Inactive Ulcerative Colitis According to the Ministry of Health, Labour and Welfare's "Diagnostic Criteria and Treatment Guidelines for Ulcerative Colitis and Crohn's Disease,", and a control group (patients visiting our department without underlying diseases, including those with non-malignant colorectal polyps).
2. Individuals aged 20 years or older.
3. Those who can provide written informed consent for participation in the study of their own free will.
Key exclusion criteria
1. Individuals taking anticoagulants listed as contraindications for biopsy in the "Guidelines for Gastrointestinal Endoscopy in Patients on Antithrombotic Therapy".
2. Individuals who are unable to provide informed consent.
3. Individuals with infectious diseases that require notification under the Infectious Diseases Control Law.
4. Individuals deemed unsuitable as subjects by the principal or sub-investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Andoh |
Organization
Shiga University of Medical Science
Division name
Department of Medicine
Zip code
520-2192
Address
Seta-Tsukinowa, Otsu, Shiga
TEL
077-548-2217
andoh@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Otsuki |
Organization
Shiga University of Medical Science
Division name
Department of Medicine
Zip code
520-2192
Address
Seta-Tsukinowa, Otsu, Shiga
TEL
077-548-2217
Homepage URL
akinori0@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
Ethics Review Board, Shiga University of Medical Science
Address
3rd Floor, Building E, Affiliated Hospital, Tsukiwaki-cho, Seta, Otsu City, Shiga Prefecture
Tel
077-548-3576
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
| 2024 | Year | 09 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
71
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 | 06 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 02 | 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
This study is a case-control study, targeting patients with ulcerative colitis who visited our facility between May 1, 2022, and April 30, 2023, who met the selection criteria and provided informed consent. The control group consisted of patients visiting our facility who met the selection criteria and also provided informed consent. Fecal samples were collected from those who consented, and clinical information was gathered at the time of collection, including age, sex, medication history, and relevant clinical details such as diarrhea and general condition necessary for the Mayo score.
Management information
Registered date
| 2024 | Year | 09 | Month | 04 | Day |
Last modified on
| 2024 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063310
