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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004143
Enrollment
10
Registered
2010-09-01
Start date
2010-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis and Crohn&#39

Interventions

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 te

Sponsors

St. Luke's International Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Public ContactKatsuyuki Fukuda

St. Luke's International Hospital Department of Gastroenterology

fukukats@luke.ac.jp03-3451-5151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026