UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024638 |
|---|---|
| Receipt number | R000028343 |
| Scientific Title | A functional analysis of intestinal microbiota affected with intestinal IgA antibody in the inflammatory bowel disease. |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2018/11/20 21:55:59 |
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Basic information
Public title
A functional analysis of intestinal microbiota affected with intestinal IgA antibody in the inflammatory bowel disease.
Acronym
IgAUC
Scientific Title
A functional analysis of intestinal microbiota affected with intestinal IgA antibody in the inflammatory bowel disease.
Scientific Title:Acronym
IgAUC
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, the enteric bacteria of a healthy subject and patients with inflammatory bowel disease is transfused into a germfree mouse and makes hybridoma from the mouse intestinal tract IgA productive cells which are stimulated by the intestinal bacterial flora of the human established in mouse intestinal tract, and are produced and identifies molecules derived from the bacteria which an IgA antibody recognizes.
It is intended that the investigation, the IgA antibody which is effective for the enteral environment maintenance of the human and a key and the target molecule that it is determine the intestinal bacterial flora analysis of each mouse individual and the relations of recognition molecules of the IgA derived from the individual.
Basic objectives2
Others
Basic objectives -Others
Similar to a mouse, we elucidate key to crosstalk molecules with the bacteria in the human and, in this study, exhibit a new strategic base of much disease prevention and treatment to occur by the break of the balance of the intestinal bacterial flora.
The intestinal bacterial flora of the human under the conventional environment is greatly different from a mouse under the SPF environment and thinks that it is essential because it applies an IgA antibody to human in the future to ascertain the target which the intestinal tract IgA antibody of the human recognizes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We can confirm that enterocolitis depression effect by the intestinal bacterial flora control of the observed W27 antibody occurs in a mouse for the intestinal bacterial flora of the patients of the human.
It can become the data base to apply an IgA antibody to human in the future to ascertain the target which the intestinal IgA antibody of the human recognizes.
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
| 15 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients with ulcerative colitis
Key exclusion criteria
1. That took antibiotics within four weeks from time of the sampling or has been put on a drip.
2. Pregnant women.
3. Fulminant ulcerative colitis.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Imaeda |
Organization
Shiga University of Medical Science
Division name
Division of Gastroenterology, Department of Medicine
Zip code
Address
Setatsukinowa, Otsu
TEL
077-548-2217
imaeda@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Imaeda |
Organization
Shiga University of Medical Science
Division name
Division of Gastroenterology, Department of Medicine
Zip code
Address
Setatsukinowa, Otsu
TEL
077-548-2217
Homepage URL
imaeda@belle.shiga-med.ac.jp
Sponsor or person
Institute
Nara Institute of Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
滋賀医科大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 01 | 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
| 2016 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Observational Study
Management information
Registered date
| 2016 | Year | 10 | Month | 30 | Day |
Last modified on
| 2018 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028343
