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
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
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
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
