UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027697 |
|---|---|
| Receipt number | R000031712 |
| Scientific Title | Analysis of intestinal epithelial adherent bacteria in IBD patient |
| Date of disclosure of the study information | 2017/06/09 |
| Last modified on | 2019/03/11 18:15:02 |
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Basic information
Public title
Analysis of intestinal epithelial adherent bacteria in IBD patient
Acronym
Analysis of intestinal epithelial adherent bacteria in IBD patient
Scientific Title
Analysis of intestinal epithelial adherent bacteria in IBD patient
Scientific Title:Acronym
Analysis of intestinal epithelial adherent bacteria in IBD patient
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We identify intestinal epitheial adherent bacteria by using electron microscope to research the relationship between pathophysiology and microbiota.
Basic objectives2
Others
Basic objectives -Others
We observe intestinal epithelium to reveal difference of structure between ulcerative colitis and non-intestinal bowel disease patients to propose new diagnostic method.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare intestinal epithelial adherent microbiota between ulerative colitis and non-intestinal bowel disease patients.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Two mucous membranes are collected from the proximal colon and the distal colon respectively when the patient has colonoscopy.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Ulcerative colitis patient
We recruit ulcerative colitis patients over 20 years old, whose disease activities are stable or unstable. Their medicines are not concern. Ethical approval is obtained from Keio University Hospital Ethics and Medical Research Committee.
Non Intestinal bowel disease patient
Patients over 20 years old, who are performed colonoscopy. They are not intestinal bowel disease.
Key exclusion criteria
1 Patients who are suspected to be affected to colitis expect ulcerative colitis.(eg.infectious coitis)
2 Pregnant women or patients who are suspected to be pregnancy.
3 Patients who take some antibiotics 30 days before having colonoscopy.
4 Patients who are affected to severe infection.
5 Patients who are affected to malignancy or having a history of it.
6 Patients undergoing chemotherapies.
7 Patients with obvious neuropsychiatric disorders.
8 Patients with history of resection of the intestinal tract (excluding history of appendectomy)
9 Patients judged inappropriate to incorporate this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Kanai |
Organization
Keio University
Division name
Gastroenterology department
Zip code
160-8582
Address
Shinano, Shinjuku, Tokyo 35
TEL
03-5363-3790
takagast@z2.keio.jp
Public contact
Name of contact person
| 1st name | Ena |
| Middle name | |
| Last name | Nomura |
Organization
Keio University
Division name
Gastroenterology department
Zip code
160-8582
Address
Shinano, Shinjuku, Tokyo 35
TEL
070-6587-4502
Homepage URL
enanomura@keio.jp
Sponsor or person
Institute
Keio university
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Keio university ethics comittee
Address
Shinano, Shinjuku, Tokyo 35
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
| 2017 | Year | 06 | Month | 09 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 05 | Month | 31 | Day |
Other
Other related information
Not in particular.
Management information
Registered date
| 2017 | Year | 06 | Month | 08 | Day |
Last modified on
| 2019 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031712
| Research Plan | |
|---|---|
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| Registered date | File name |
| Research case data | |
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