UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000031712