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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027697
Receipt No. 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

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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
Email 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
Email enanomura@keio.jp

Sponsor
Institute Keio university
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031712

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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