UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024638
Receipt No. 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

* 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 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
Email 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
Email imaeda@belle.shiga-med.ac.jp

Sponsor
Institute Nara Institute of Science and Technology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028343

Research Plan
Registered date File name
2017/01/12 倫理委員会審査申請書(炎症性疾患における便中IgA抗体の機能解析)ver3.3.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.