Clinical trial · Interventional
Immune Modulation by Parenteral Fish Oil in Patients With Crohn's Disease
Modulation of Immune Function by Parenteral Fish Oil in Patients With Crohn's Disease and High Inherent Tumor Necrosis Factor-alpha Production: a Randomized, Single Blinded, Cross-over Study
NCT02349594CI-TRIAL-00019752completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Crohn Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intralipid 20% | Drug | — | UNRESOLVED |
| Omegaven 10% | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- treatment order A
- description
- Participants in this arm first receive 'Omegaven 10%' and after crossing over the 'Intralipid 20%'
- interventionNames
- Drug: Omegaven 10%
- Drug: Intralipid 20%
- type
- ACTIVE_COMPARATOR
- label
- treament order B
- description
- Participants in this arm first receive 'Intralipid 20%' and after crossing over the 'Omegaven 10%'
- interventionNames
- Drug: Omegaven 10%
- Drug: Intralipid 20%
Primary outcomes (1)
- measure
- Change of TNF-α production in pg/ml
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.