UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052851 |
|---|---|
| Receipt number | R000060297 |
| Scientific Title | Study on the usefulness of Carbonic Anhydrase I (CA I) protein as an enteritis biomarker in faeces and colonic tissue from patients with ulcerative colitis and its effect on the intestinal microbiota. |
| Date of disclosure of the study information | 2023/11/20 |
| Last modified on | 2025/05/19 09:44:17 |
* 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
Study on the usefulness of Carbonic Anhydrase I (CA I) protein in patients with ulcerative colitis and its effect on the intestinal microbiota.
Acronym
UC-CA1 Study
Scientific Title
Study on the usefulness of Carbonic Anhydrase I (CA I) protein as an enteritis biomarker in faeces and colonic tissue from patients with ulcerative colitis and its effect on the intestinal microbiota.
Scientific Title:Acronym
UC-CA1 Study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify how CA I fluctuates in faeces and colonic epithelial cells of patients with ulcerative colitis during enteritis, and to determine whether hCAI protein, which increases or decreases in faeces during enteritis, can serve as a biomarker. Quantification of CA I in faeces can predict the extent of enteritis without the need for colonoscopy, and it would be of great benefit to patients if a cut-off value could be identified to measure the risk of recurrence of enteritis or the need for intensified treatment, including in the clinical course. The aim is also to clarify in humans the changes in the gut microbiota associated with increases or decreases in CA I that have been identified at the mouse level, in order to investigate the underlying mechanisms of onset and exacerbation of enteritis and to evaluate the beneficial gut bacteria and other factors.
The possibility of hCAI functioning as a biomarker in patients with inflammatory bowel disease and its correlation with intestinal bacteria will be analysed by collecting samples of CAI protein in tissue and faeces of patients with ulcerative colitis by biopsy during endoscopy, quantifying them later, and examining their correlation with clinical scores and mucosal healing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determine whether CA I can be a biomarker for ulcerative colitis.
Key secondary outcomes
To determine the role of CA1 protein, which increases or decreases in the gut of patients with ulcerative colitis, during enteritis (in relation to the gut microbiota and faecal metabolites).
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Ulcerative and non-ulcerative colitis patients scheduled for colonoscopy
Key exclusion criteria
When a research subject declines to participate in research or withdraws consent.
If it is found after enrolment that the subject does not meet eligibility criteria.
If the study as a whole is discontinued
If the research physician decides that it is appropriate to discontinue the research
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Tange |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
791-0295
Address
8F, Main Building, Faculty of Medicine, Ehime University, 454 Shizugawa, Toon, Ehime, Japan
TEL
0899605308
3naika@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Mirai |
| Middle name | |
| Last name | Hayashi |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Gastroenterology and Metabology
Zip code
791-0295
Address
8F, Main Building, Faculty of Medicine, Ehime University, 454 Shizugawa, Toon, Ehime, Japan
TEL
0899605308
Homepage URL
3naika@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Ehime University Hospital
Address
454 Shitsukawa, Toon, Ehime
Tel
0899605172
rinri@m.ehime-u.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
| 2023 | Year | 11 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: case-control study
Method of recruitment: patients presenting at the institution between 1 October 2023 and 31 March 2026 who met the selection criteria
Measurements: colonic mucosal CA I protein, faecal occult blood, fecal calprotectin, intestinal microbiota, CRP, erythrocyte sedimentation rate, LRG, white blood cells, etc.
Progress: as of 19 May 2025, the number of patients entered into this clinical study is 73 (57 ulcerative colitis patients, 16 non-ulcerative colitis patients) and the total number of cases tested is 66 (52 ulcerative colitis patients, 14 non-ulcerative colitis patients).
Management information
Registered date
| 2023 | Year | 11 | Month | 20 | Day |
Last modified on
| 2025 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060297
