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

未提供0 个研究点开始时间: 2013年6月18日最近更新: 2013年11月4日

适应症

试验速览

暂无简介。

•-Histologically proven Crohn’s disease in the ileum or colon
•-Previous bowel surgery because of Crohn’s disease activity (> 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 85
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•- 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 <18 yrs
•- Allergy for one of the following components: fish, chicken, eggs or soy beans

发起方

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