UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017179
Receipt number 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 02:03:31

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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