Immune modulation by parenteral Fish oil in patients with Crohn’s disease

Conditions: Crohn's disease
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2013-001212-30-NL

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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) <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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br><br>post supplementation early effects: day 4 (= 1 day after the last infusion)<br><br>post supplementation late effects: day 11 (= 8 days after the last infusion)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Ex vivo production of relevant cytokines <br>- Serum levels of TNF-a<br>- Analysis of SNPs related with a high inherent TNF-a production<br>- leukocyte function tests;Timepoint(s) of evaluation of this end point: pre supplementation (day 0)<br><br>post supplementation early effects: day 4 (= 1 day after the last infusion)<br><br>post supplementation late effects: day 11 (= 8 days after the last infusion)