Immune Modulation by Parenteral Fish Oil in Patients With Crohn's Disease

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the effects of infusion of a Fish oil-based lipid emulsion on TNF-α production and other relevant immune functions. A soybean oil emulsion, rich in the omega-6 polyunsaturated fatty acid linoleic acid, will serve as control.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Treatments: Soybean oil, phospholipid emulsion

Criteria

Inclusion Criteria:

• Adult patients with Crohn's disease with previous bowel surgery, currently in remission (without the need for immunosuppressive drugs) and with a high inherent TNF-α production.

Exclusion Criteria:

• Patients with other active inflammatory / immune mediated underlying diseases

• Smoking > 5 cigarettes a day

• Diet with >2 portions of fatty fish (tuna, salmon, mackerel, herring, and trout) 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 than 5-aminosalicylic acid preparations) or surgical treatment for Crohn's disease activity

• Use of non-steroidal anti-inflammatory drugs or aspirin

• 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