NL-OMON50664招募中不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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.
排除标准
- •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.
研究者
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