UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004185 |
|---|---|
| Receipt number | R000005029 |
| Scientific Title | Functional analysis of oligosaccharides in B cells of inflammatory bowel disease patients |
| Date of disclosure of the study information | 2010/09/10 |
| Last modified on | 2014/12/28 10:26:18 |
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Basic information
Public title
Functional analysis of oligosaccharides in B cells of inflammatory bowel disease patients
Acronym
Analysis of oligosaccharides in inflammatory bowel diseases
Scientific Title
Functional analysis of oligosaccharides in B cells of inflammatory bowel disease patients
Scientific Title:Acronym
Analysis of oligosaccharides in inflammatory bowel diseases
Region
| Japan |
Condition
Condition
Inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the cause and roles of oligosaccharide alterations of B cells in inflammatory bowel patients
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oligosaccharide structure of B cells in inflammatory bowel disease patients
Key secondary outcomes
Expression of oligosaccharide-related enzymes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with inflammatory bowel diseases (ulcerative colitis and Crohn's disease), rheumatoid arthritis, IgA nephritis treated in Osaka University Hospital and healthy volunteers
Key exclusion criteria
Subjects with anemic symptoms and blood hemoglobin levels lower than 10g/dl.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Iijima |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
0668793621
hiijima-gi@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Iijima |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka
TEL
066879-3621
Homepage URL
hiijima@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of gastroenterology and Hepatology, Osaka University Graduate School of Medicine
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
Address
Tel
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
| 2010 | Year | 09 | Month | 10 | 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
| 2009 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 05 | Month | 01 | Day |
Other
Other related information
Mononuclear cells are obtained from anonymous serum and biopsy samples. These cells are infected with EB virus to obtain immortalized cells. Analyze the cell function, oligosaccharides in produced antibodies and enzyme activity for oligosaccharide production.
Management information
Registered date
| 2010 | Year | 09 | Month | 10 | Day |
Last modified on
| 2014 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005029
