NL-OMON40244招募中2 期
Modulation of immune function by parenteral fish oil in patients with Crohn*s disease and high inherent Tumor Necrosis Factor-alfa production, a randomized, single blinded, cross-over study - Immune modulation with parenteral fish oil in Crohn*s disease
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-Histologically proven Crohn*s disease in the ileum or colon;-Previous bowel surgery because of Crohn*s disease activity ( more than 6 months before screening) ;-Currently in remission (Crohn*s Disease Activity Index (CDAI) <150);-No use of one the following immunosuppressive drugs (or its variants) within the last 6 months : corticosteroids (with exclusion of inhalation- or dermatological ointment containing steroids), methotrexate, thiopurines, anti-TNF-a agents, cyclosporine, tacrolimus, sirolimus or Cellcept® ;-Willingness and ability to give written informed consent
排除标准
- •- Incapacitated people (people unable to reasonably judge -what is in their own interests);- Patients with other active inflammatory / immune mediated underlying diseases;- Smoking > 5 cigarettes a day [70];- Diet with >2 portions of fatty fish (tuna, salmon, mackerel, herring, trout and haring) a week;- History of metabolic disorder (especially diabetes or lipid disorders);- Crohn*s disease activity, including the presence of active fistulas ;- On need for medical (other that 5-ASA preparations) or surgical treatment for Crohn*s disease activity;- Use of NSAIDs or asprin;- C-reactive protein levels of >10 mg/l ;- History of venous or arterial thrombosis;- Active malignancy ;- Presence of severe pulmonary, cardiovascular, renal, liver, coagulation or hematological disease;- Pregnancy or lactation ;- Age above;18 yrs;- Allergy for one of the following components: fish, chicken, eggs or soy beans
研究者
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