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Clinical Trials/NL-OMON50664
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

Academisch Medisch Centrum0 sites20 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational invasive

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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