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

Phase 2

Recruiting

• Conditions: Crohn's disease; inflammatory bowel disease; 10017969

• Registration Number: NL-OMON40244
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

-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

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified