UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the usefulness for the treatment of ulcerative colitis through the change of enterobacterial flora derived by adacolumn treatment.
Title of the study (Brief title)	The usefulness through enterobacterial flora by adacolumn treatment.
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To investigate the usefulness of adacolumn (referred to GMA) for the treatment of ulcerative colitis (UC) in view of the change of enterobacterial flora before and after GMA therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationship between the change of enterobacterial flora and improvement of endoscopic finding, clinical symptoms.
Key secondary outcomes	The change of inflammatory related gene expression in colonic mucosa after GMA treatment.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	granulocyte and monocyte apheresis (GMA), twice per week, 5 weeks continuously, total 10 times.
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Over 4 points of Lichtiger index score and endoscopic Mayo score 2 and 3. A kind of the previous treatment and the concomitant drug do not matter The patient who judged that GMA treatment was appropriate along guidelines on Ministry of Health, Labour and Welfare
Key exclusion criteria	a) The re-registration patients for this study b) The number of granulocyte is under 2,000/mm3 c) A patient complicated with a serious infectious disease d) Patient with a serious heart trouble e) Patient with a serious renal trouble f) Patient with low blood pressure (maximum pressure is under 80mmHg) g) Patient with pregnancy h) Strength sthenia pro-extreme dehydration, solidification, patient of serious anemia (less than 8.0 g/dL of hemoglobin) i) Patient with malignant tumor j) Patient with stoma k) Patient who had surgery for intestine with 12 weeks l) Patient with serious complications out of intestinal tract m) Patient who had GMA treatment within 4 weeks n) Patient who had started or increased thiopurine within 8 weeks o) The patient who judged an arrangement to the final examination if the medical attendant was inappropriate
Target sample size	100

Research contact person
Name of lead principal investigator	Yuji Naito
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular Gastroenterology and Hepatology
Address	465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Kyoto, Japan
TEL	075-251-5519
Email	ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person	Kazuhiko Uchiyama
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Molecular Gastroenterology and Hepatology
Address	465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Kyoto, Japan
TEL	075-251-5519
Homepage URL
Email	k-uchi@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine, Department of Molecular Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization	Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 06 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 06 Month 01 Day
Anticipated trial start date	2015 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 04 Month 20 Day
Last modified on	2018 Year 07 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019935