Ulcerative colitis and Crohn'
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Moderate, severe and fulminating active ulcerative colitis. Nutrition therapy or conventional medication resistant Crohn's disease with large bowel lesion involvement.
Exclusion criteria
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
St. Luke's International Hospital Department of Gastroenterology