NL-OMON50664
Recruiting
Not Applicable
An exploratory analysis of markers in blood, faeces and the colonic mucosa regarding response to treatment with infliximab for acute severe ulcerative colitis - Mechanisms for Infliximab (non)response in acute severe ulcerative colitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- inflammatory bowel disease
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. At least 16 years of age.
- •2\. A documented diagnosis of UC prior to entry into the study, based on
- •clinical, biochemical, endoscopic and histological findings(14\).
- •3\. ASUC as defined by the Truelove and Witts criteria as six or more stools a
- •day with either large amounts of blood per stool, a temperature over 37\.8 °C, a
- •heart rate above 90 bpm, hemoglobin levels of less than 10\.5 g/dL, or an
- •erythrocyte sedimentation rate over 30 mm/h(1\).
- •4\. Patients not responding to intravenous corticosteroid treatment and
- •receiving IFX as rescue therapy
- •5\. Patients who are not yet candidates for emergency colectomy.
Exclusion Criteria
- •1\.Other cause of colitis: indeterminate colitis, microscopic colitis, ischemic
- •colitis, infectious colitis, or clinical findings suggestive of Crohn\*s
- •2\.Positive stool examinations for enteric pathogens, pathogenic ova or
- •parasites, or Clostridium difficile toxin.
- •3\.Contra\-indications to anti\-TNFa treatment (TBC, severe infections or
- •congestive heart failure)
- •4\.IFX or any other anti\-TNFa therapy in the past six months.
- •5\. Pregnant or lactating females.
Outcomes
Primary Outcomes
Not specified
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