An exploratory analysis of markers in blood, faeces and the colonic mucosa regarding response to treatment with infliximab for acute severe ulcerative colitis

Recruiting

Conditions: inflammatory bowel disease
ulcerative colitis
10017969

Registration Number: NL-OMON50664

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

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.
6. Signed and dated informed consent.

Exclusion Criteria

1.Other cause of colitis: indeterminate colitis, microscopic colitis, ischemic
colitis, infectious colitis, or clinical findings suggestive of Crohn*s
disease.
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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters are 1) the inflammatory protein levels and 2) the IFX<br /><br>induced macrophage levels measured in blood and mucosal tissue, compared<br /><br>between responders and non-responders at baseline and post IFX. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>i. IFX levels measured in blood, feces, and mucosal tissue, compared between<br /><br>responders and non-responders.<br /><br>ii. MMP activity measured in blood, feces, and mucosal tissue, compared between<br /><br>responders and non-responders at baseline and post IFX.<br /><br>iii. Anti-drug antibodies measured in blood, compared between responders and<br /><br>non-responders.<br /><br>iv. Changes in inflammatory protein levels measured in blood and mucosal<br /><br>tissue, compared between baseline and post IFX.</p><br>