Unique ID issued by UMIN | UMIN000004143 |
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Receipt number | 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 16:44:45 |
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
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
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
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
Japan |
Ulcerative colitis and Crohn's disease
Gastroenterology |
Others
NO
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.
Efficacy
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.
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
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.
16 | years-old | < |
Not applicable |
Male and Female
Moderate, severe and fulminating active ulcerative colitis.
Nutrition therapy or conventional medication resistant Crohn's disease with large bowel lesion involvement.
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
10
1st name | |
Middle name | |
Last name | Katsuyuki Fukuda |
St. Luke's International Hospital
Department of Gastroenterology
9-1, Akashi-cho, Chuo-ku, Tokyo 104-8560 JAPAN
03-3541-5151
fukukats@luke.ac.jp
1st name | |
Middle name | |
Last name | Katsuyuki Fukuda |
St. Luke's International Hospital
Department of Gastroenterology
9-1, Akashi-cho, Chuo-ku, Tokyo 104-8560 JAPAN
03-3451-5151
fukukats@luke.ac.jp
St. Luke's International Hospital
JIMRO Co., Ltd.
Profit organization
JAPAN
NO
聖路加国際病院(東京都)
2010 | Year | 09 | Month | 01 | Day |
Unpublished
Terminated
2010 | Year | 04 | Month | 27 | Day |
2010 | Year | 04 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2011 | Year | 07 | Month | 01 | Day |
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2011 | Year | 12 | Month | 01 | Day |
2010 | Year | 09 | Month | 01 | Day |
2015 | Year | 04 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004975
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