UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047219 |
|---|---|
| Receipt number | R000053854 |
| Scientific Title | Analysis of gastrointestinal mucosal lymphocyte composition of ileoanal anastomosis (J-pouch) |
| Date of disclosure of the study information | 2022/03/18 |
| Last modified on | 2024/10/11 14:53:17 |
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Basic information
Public title
Analysis of gastrointestinal mucosal lymphocyte composition of ileoanal anastomosis (J-pouch)
Acronym
Analysis of gastrointestinal mucosal lymphocyte composition of ileoanal anastomosis (J-pouch)
Scientific Title
Analysis of gastrointestinal mucosal lymphocyte composition of ileoanal anastomosis (J-pouch)
Scientific Title:Acronym
Analysis of gastrointestinal mucosal lymphocyte composition of ileoanal anastomosis (J-pouch)
Region
| Japan |
Condition
Condition
Patients with ileoanal anastomosis (J-pouch)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze gastrointestinal mucosal lymphocyte composition of ileoanal anastomosis (J-pouch)
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference in lymphocyte composition between patients with and without pouchitis in the ileoanal anastomosis (J-pouch)
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with ileoanal anastomosis (J-pouch)
Key exclusion criteria
Women who are pregnant or may become pregnant
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Iwamuro |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku
TEL
0862357218
iwamuromasaya@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Iwamuro |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku
TEL
0862357218
Homepage URL
iwamuromasaya@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
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
Okayama University Hospital
Address
2-5-1 Shikata-cho, Kita-ku
Tel
0862357218
iwamuromasaya@yahoo.co.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 | 18 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
https://www.cureus.com/articles/292715-decreased-cd3cd56-natural-killer-t-lymphocytes-and-increased-
Number of participants that the trial has enrolled
15
Results
In patients with ulcerative colitis with erosions/ulcers (UC-UE group), CD56+/CD3+ and CD8+/CD3+ ratios were significantly lower than in the familial adenomatous polyposis (FAP) group, indicating disrupted natural killer T-cell populations. Immunohistochemical analysis showed varying lymphocyte distribution among non-inflamed mucosa, dense infiltration, and lymphoid follicles, with CD56+ cells less abundant in dense areas and HLA-DR+ cells more prevalent.
Results date posted
| 2024 | Year | 10 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We prospectively analyzed endoscopic biopsy specimens from the ileal pouches of 15 patients and categorized them into three groups: FAP, ulcerative colitis with an inflammation-free pouch (UC-I), and ulcerative colitis with ulcers and/or erosions in the pouch (UC-UE).
Participant flow
We prospectively analyzed endoscopic biopsy specimens from the ileal pouches of 15 patients and categorized them into three groups: FAP, ulcerative colitis with an inflammation-free pouch (UC-I), and ulcerative colitis with ulcers and/or erosions in the pouch (UC-UE).
Adverse events
Not occurred
Outcome measures
Flow cytometry was used to assess various T-lymphocyte markers, including cluster of differentiation (CD) 4, CD8, CD56, and human leukocyte antigen (HLA)-DR. Immunohistochemistry was performed to visualize the spatial distribution of CD3+, CD56+, and HLA-DR+ cells in the pouch mucosa.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | 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 | 18 | Day |
Last modified on
| 2024 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053854
