Home Parenteral Nutrition, Short Bowel Syndrome
Conditions
Brief summary
Soybean oil based IV fat emulsion (IVFE) has been one of the sole sources of IVFE in the US. Soybean oil based IVFE has higher ratio of omega-6 to omega-3 fatty acids and can be associated with a number of complications including inflammation, abnormal liver function tests (reflecting steatosis, cholestasis, etc.), and metabolic abnormalities. Recently the FDA has approved SMOFlipid which contains a mixture of soybean oil, medium chain triglycerides, olive oil, and fish oil. It provides a more positive ratio of omega-3 to omega-6 fatty acids and has been shown in short term trials to be beneficial in cases of intolerance to soybean oil IVFE. This study is designed to investigate the impact of SMOFlipid in prolonged use.
Interventions
DRUGSMOFLipid
SMOFlipid is a lipid emulsion formed using soybean oil, medium chain triglycerides, olive oil, and fish oil.
DRUGStandard therapy
In most cases standard therapy will be IntraLipid.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than 18 years * current Mayo Clinic HPN patient, able to provide informed consent, anticipated duration of HPN greater than 3 months * infusion company is able to provide SMOFlipid * no history of alcohol addiction * noted to be intolerant to SO based IVFE as defined below.
Exclusion criteria
* Pregnant women * failure to provide consent * patients who are deemed to be on HPN for less than three months * patients who have previous proven addiction and dependence to alcohol/ heavy alcohol consumption reported (during history or reported in the EMR), known hypersensitivity to fish, egg, or soy, patients who will not be managed by the Mayo Clinic HPN team and patients who have active infection (as determined by the clinician) at the time of enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AST | 3-12 months | Primary aim is to assess impact on AST (liver enzyme) |
| Glucose | 3-12 months | blood glucose |
| Triglycerides | 3-12 months | blood triglycerides |
| ALT | 3-12 months | liver enzyme |
| Total bilirubin | 3-12 months | Liver study |
| CRP | 3-12 months | inflammatory marker |
Countries
United States
Outcome results
None listed