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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017179
Receipt No. R000019935
Scientific Title Examination of the usefulness for the treatment of ulcerative colitis through the change of enterobacterial flora derived by adacolumn treatment.
Date of disclosure of the study information 2015/06/01
Last modified on 2018/07/15

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Basic information
Public title Examination of the usefulness for the treatment of ulcerative colitis through the change of enterobacterial flora derived by adacolumn treatment.
Acronym The usefulness through enterobacterial flora by adacolumn treatment.
Scientific Title Examination of the usefulness for the treatment of ulcerative colitis through the change of enterobacterial flora derived by adacolumn treatment.
Scientific Title:Acronym 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
1st name
Middle name
Last name Yuji Naito
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology and Hepatology
Zip code
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
1st name
Middle name
Last name Kazuhiko Uchiyama
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology and Hepatology
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2015 Year 06 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 Open public recruiting
Date of protocol fixation
2015 Year 06 Month 01 Day
Date of IRB
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

Other
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

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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