Crohn's disease
Conditions
Interventions
Trade Name: Omegaven
Pharmaceutical Form: Emulsion for infusion
Trade Name: Intralipid 10%
Pharmaceutical Form: Solution for infusion
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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) =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
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 <18 yrs - Allergy for one of the following components: fish, chicken, eggs or soy beans
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effects of infusion of a FO-based lipid emulsion on TNF-a production in patients with Crohn's disease;Secondary Objective: To evaluate the effects of infusion of a FO-based lipid emulsion on other relevant immune functions in patients with Crohn's disease;Primary end point(s): difference in pre- and post supplementation TNF-a production by LPS stimulated Peripheral Blood Mononuclear Cells;Timepoint(s) of evaluation of this end point: pre supplementation (day 0) post supplementation early effects: day 4 (= 1 day after the last infusion) post supplementation late effects: day 11 (= 8 days after the last infusion) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Ex vivo production of relevant cytokines - Serum levels of TNF-a - Analysis of SNPs related with a high inherent TNF-a production - leukocyte function tests;Timepoint(s) of evaluation of this end point: pre supplementation (day 0) post supplementation early effects: day 4 (= 1 day after the last infusion) post supplementation late effects: day 11 (= 8 days after the last infusion) | — |
Countries
Netherlands
Outcome results
None listed