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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004143
Receipt No. R000004975
Scientific Title An explorative study of T-FRAP analysis for intestinal flora and HGF level of GMA (granulocyte and monocyte absorption) for ulcerative colitis and Crohn's disease
Date of disclosure of the study information 2010/09/01
Last modified on 2015/04/10

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Basic information
Public title An explorative study of T-FRAP analysis for intestinal flora and HGF level of GMA (granulocyte and monocyte absorption) for ulcerative colitis and Crohn's disease
Acronym An explorative study of T-FRAP analysis for intestinal flora and HGF level of GMA (granulocyte and monocyte absorption) for ulcerative colitis and Crohn's disease
Scientific Title An explorative study of T-FRAP analysis for intestinal flora and HGF level of GMA (granulocyte and monocyte absorption) for ulcerative colitis and Crohn's disease
Scientific Title:Acronym An explorative study of T-FRAP analysis for intestinal flora and HGF level of GMA (granulocyte and monocyte absorption) for ulcerative colitis and Crohn's disease
Region
Japan

Condition
Condition Ulcerative colitis and Crohn's disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare patients' intestinal flora with T-RFLP analysis about before and after GMA (granulocyte and monocyte absorption) for ulcerative colitis and Crohn's disease then to examine their disease activities. And to examine the efficacy of monitoring for changes of serum HGF level and disease activity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary measurement is relationship between change of intestinal flora and disease activity at the end of the study. Clinical remission is defined as CAI<=4 for ulcerative colitis and CDAI<=150 for Crohn's disease.
Key secondary outcomes 1. Clinical response at the end of the study. Clinical response is defined as reduction of CAI more than 4 points for ulcerative colitis and CDAI more than 50 points for Crohn's disease
2. Reduction in CAI and CDAI
3. Reduction in CRP
4. Assessment for colonoscopic findings
5. Safety assessment

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 Patients receive GMA treatment the maximum number of treatment allowed is eleven for ulcerative colitis.
Patients receive one GMA treatment per week and the maximum number of treatment allowed is ten for Crohn's disease.
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
16 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Moderate, severe and fulminating active ulcerative colitis.
Nutrition therapy or conventional medication resistant Crohn's disease with large bowel lesion involvement.
Key exclusion criteria 1. Granulocyte count is equal to or less than 2,000/mm3
2. Serious infectious disease
3. Serious heart disease
4. Serious kidney disease
5. Hypotension (less than maximal blood pressure 80mmHg)
6. Pregnancy
7. Serious exsiccation / serious coagulation, serious anemia
8. Massive bleeding, perforation, toxic megacolon
9. Concomitant drug that would affect platelet function and coagulation system
10. Deep thrombophlebitis
11. Severe intestinal stricture that needs surgery
12. Previous surgery
13. Permanent stoma
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuyuki Fukuda
Organization St. Luke's International Hospital
Division name Department of Gastroenterology
Zip code
Address 9-1, Akashi-cho, Chuo-ku, Tokyo 104-8560 JAPAN
TEL 03-3541-5151
Email fukukats@luke.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuyuki Fukuda
Organization St. Luke's International Hospital
Division name Department of Gastroenterology
Zip code
Address 9-1, Akashi-cho, Chuo-ku, Tokyo 104-8560 JAPAN
TEL 03-3451-5151
Homepage URL
Email fukukats@luke.ac.jp

Sponsor
Institute St. Luke's International Hospital
Institute
Department

Funding Source
Organization JIMRO Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

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 聖路加国際病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 09 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 Terminated
Date of protocol fixation
2010 Year 04 Month 27 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 07 Month 01 Day
Date trial data considered complete
2011 Year 08 Month 01 Day
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 09 Month 01 Day
Last modified on
2015 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004975

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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