SMOFLipid in Patients Who Are Intralipid Intolerant

Short Bowel Syndrome Clinical Trial

Official title:

Safety and Efficacy of SMOFlipid in Patients Intolerant to Intralipid.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03054948
• Other study ID #: 16-009516
• Status: Withdrawn
• Phase: Phase 4
• First received: February 8, 2017
• Last updated: March 20, 2018
• Start date: February 1, 2017
• Est. completion date: March 20, 2018

Study information

• Verified date: March 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 20, 2018
• Est. primary completion date: March 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Home Parenteral Nutrition
• Short Bowel Syndrome

Intervention

Drug:
• SMOFLipid
SMOFlipid is a lipid emulsion formed using soybean oil, medium chain triglycerides, olive oil, and fish oil.
• Standard therapy
In most cases standard therapy will be IntraLipid.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AST	Primary aim is to assess impact on AST (liver enzyme)	3-12 months
Primary	Glucose	blood glucose	3-12 months
Primary	Triglycerides	blood triglycerides	3-12 months
Primary	ALT	liver enzyme	3-12 months
Primary	Total bilirubin	Liver study	3-12 months
Primary	CRP	inflammatory marker	3-12 months