SMOFlipid for Malnutrition

Recruiting at 3 trial locations

Overseen By Martin Stumpf, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Fresenius Kabi

Must be taking: Parenteral nutrition

Must not be taking: Other lipid emulsions

Disqualifiers: Hyperlipidemia, Cardiopulmonary instability, Liver conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks to 1 year

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests SMOFlipid, a specialized type of nutrition administered intravenously (parenteral nutrition), to determine its effectiveness in preventing complications such as EFAD (essential fatty acid deficiency) and PNAC (parenteral nutrition-associated cholestasis) in patients requiring long-term nutrition support. It is open to individuals aged one month and older who need most of their nutrition through IV for at least eight weeks. Suitable candidates rely heavily on parenteral nutrition and are expected to continue doing so, but should not have certain allergies or conditions like severe lipid metabolism disorders. As a Phase 4 trial, SMOFlipid has already received FDA approval and demonstrated effectiveness, and this research aims to understand its benefits for a broader patient population.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used any other lipid injectable emulsion than SMOFlipid within 6 months before joining the study.

What is the safety track record for SMOFlipid?

Research has shown that SMOFlipid is safe and effective for providing calories and essential fatty acids to individuals requiring parenteral nutrition, which is nutrition delivered through a vein. The FDA has approved it for this use. Studies have found that patients generally tolerate SMOFlipid well, with no major reports of serious side effects. However, minor side effects can occur and should be monitored. SMOFlipid, a blend of different oils, has been used safely in hospitals, making it a reliable choice for those needing long-term parenteral nutrition. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for malnutrition, which often involve simple caloric supplements or traditional parenteral nutrition solutions, SMOFlipid® is a lipid injectable emulsion that offers a unique blend of four different lipids: soybean oil, medium-chain triglycerides, olive oil, and fish oil. This combination is designed to provide a more balanced and comprehensive nutritional profile, potentially improving patient outcomes by better mimicking the body's natural lipid composition. Researchers are excited about SMOFlipid® because it could enhance the absorption and utilization of nutrients, offering a more effective approach to addressing malnutrition, especially in those who require intravenous nutrition.

What is the effectiveness track record for SMOFlipid in treating malnutrition?

Research has shown that SMOFlipid can lower the risk of liver problems in patients receiving IV nutrition. Studies have found that SMOFlipid improves the body's ability to process fats. It is also associated with better health outcomes for hospitalized patients needing IV nutrition, including a reduced risk of in-hospital mortality. Although some risks exist, such as an increased chance of infection in certain cases, SMOFlipid offers clear benefits for managing nutrition-related issues. ^{5 6 7 8 9}

Who Is on the Research Team?

Jeffrey Rudolph, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for male or female patients, at least 1 month old, who need parenteral nutrition (PN) for most of their energy needs and expect to continue needing it for over 8 weeks. It's not suitable for those with certain liver issues, blood disorders, severe infections or renal failure, pregnant or breastfeeding women, participants in other trials, recent users of different lipid emulsions, or people allergic to fish, egg, soybean or peanut proteins.

Inclusion Criteria

I am at least 1 month old.

I get most of my nutrition through IV and will continue to do so for the next 56 days.

I need parenteral nutrition for at least 5 days a week.

Exclusion Criteria

My blood tests show high levels of fats.

I have a genetic disorder affecting how my body processes amino acids.

I have been diagnosed with hemophagocytic syndrome.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SMOFlipid for parenteral nutrition to evaluate the risk of developing EFAD and/or PNAC

8 weeks to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SMOFlipid

Trial Overview The study tests SMOFlipid®, a type of fat given through the veins (lipid injectable emulsion), to see if it prevents essential fatty acid deficiency (EFAD) and parenteral nutrition-associated cholestasis (PNAC) in patients who rely on PN as their main source of nutrients.

How Is the Trial Designed?

Group I: Single arm SMOFlipid® (lipid injectable emulsion) Experimental Treatment 1 Intervention

Investigational drug: SMOFlipid® (lipid injectable emulsion).

SMOFlipid is already approved in United States, European Union for the following indications:

Approved in United States as SMOFlipid for:

• Parenteral nutrition for adults and pediatric patients, including term and preterm neonates, when oral or enteral nutrition is not possible, insufficient, or contraindicated

Approved in European Union as SMOFlipid for:

• Parenteral nutrition for adults and pediatric patients, including term and preterm neonates, when oral or enteral nutrition is not possible, insufficient, or contraindicated

Who Is Running the Clinical Trial?

Fresenius Kabi

Lead Sponsor

Trials

83

Recruited

1,138,000+

Pierluigi Antonelli

Fresenius Kabi

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Degree in Economics from L.U.I.S.S.

Dr. John Young

Fresenius Kabi

Chief Medical Officer since 2023

MD from Harvard Medical School

Published Research Related to This Trial

Intravenous lipid emulsions provide an effective source of calories and help prevent essential fatty acid deficiency, contributing to prolonged survival in patients with conditions like short bowel syndrome.

While serious adverse effects are rare with newer lipid emulsions, a case of pulmonary lipid-fibrin emboli linked to chronic hyperalimentation highlights the need for careful monitoring in patients receiving these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary lipid emboli in association with long-term hyperalimentation. Kitchell, CC., Balogh, K.[2019]

In a study involving 40 patients undergoing gastrointestinal surgery, SMOFlipid 20% showed a significantly lower increase in triglyceride levels compared to the MCT/LCT emulsion (Lipovenoes 20%) after 6 days.

Both emulsions had similar effects on inflammatory markers, but SMOFlipid's balanced fatty acid composition and high vitamin E content suggest it may be a more beneficial option for managing triglyceride levels in surgical patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of new intravenous lipid (SMOFlipid 20%) versus medium-chain triglycerides/long-chain triglycerides in adult patients undergoing gastrointestinal surgery. Wu, MH., Wang, MY., Yang, CY., et al.[2018]

In a study of 150 infants receiving prolonged parenteral nutrition for at least 28 days, those treated with SMOFlipid had significantly lower levels of conjugated bilirubin compared to those treated with Intralipid, indicating a potential protective effect against cholestasis.

The incidence of cholestasis was notably lower in the SMOFlipid group (4.5%) compared to the Intralipid group (20%), suggesting that SMOFlipid may be a safer option for infants at risk of liver complications during long-term parenteral nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a lipid injectable emulsion (SMOF) on conjugated bilirubin levels in children receiving prolonged parenteral nutrition: A large single center experience. Navaratnarajah, N., Girard, G., Sant'Anna, G., et al.[2022]

In a study involving 199 postoperative patients, SMOFlipid, a new lipid emulsion, was found to be clinically safe and well tolerated, showing no significant differences in safety parameters compared to standard soybean oil emulsion.

There was a trend indicating that patients receiving SMOFlipid had a shorter length of hospital stay (15.7 days) compared to those receiving standard emulsion (17.8 days), suggesting potential benefits in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a new parenteral lipid emulsion (SMOFlipid) in surgical patients: a randomized, double-blind, multicenter study. Mertes, N., Grimm, H., Fürst, P., et al.[2006]

In a study involving 28 pediatric patients on home parenteral nutrition, SMOFlipid 20% was found to be safe and well tolerated, showing no significant differences in liver enzyme safety parameters compared to standard soybean oil emulsion.

SMOFlipid 20% significantly decreased plasma bilirubin levels and increased levels of beneficial omega-3 fatty acids and alpha-tocopherol, indicating improved nutritional status without affecting lipid peroxidation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new intravenous fat emulsion containing soybean oil, medium-chain triglycerides, olive oil, and fish oil: a single-center, double-blind randomized study on efficacy and safety in pediatric patients receiving home parenteral nutrition. Goulet, O., Antébi, H., Wolf, C., et al.[2022]

In a study of 20 pediatric patients with intestinal failure, transitioning to SMOFlipid from soybean oil or a fish-oil combination resulted in increased levels of ω-6 fatty acids, which are important for growth and development, without negatively affecting ω-3 fatty acids or liver function.

The use of SMOFlipid over 1.5 years showed positive trends in growth metrics, such as body mass index and length, indicating that it is a safe and effective alternative for providing essential fatty acids in pediatric patients on parenteral nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of SMOFlipid in Pediatric Intestinal-Failure Patients and Its Effects on Essential Fatty Acid Levels. Ho, BE., Chan, SC., Faino, AV., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0899900723002496

Effect of SMOF lipid emulsion on physical growth and ... Compared with MCT/LCT, SMOF can reduce the risk for parenteral nutrition-associated cholestasis and metabolic bone disease of prematurity. •. SMOF was an ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9573282/

SMOFlipid Impact on Growth and Neonatal Morbidities in Very ... SMOFlipid was associated with lower growth velocity and BPD but higher rate of late-onset sepsis—it is a double-edged sword ...

3. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2016/207648lbl.pdf

SMOFLIPID (lipid injectable emulsion) - accessdata.fda.gov The risk of infection is increased in patients with malnutrition-associated immunosuppression, long-term use and poor maintenance of intravenous catheters, or ...

4. nature.com nature.com/articles/s41430-023-01288-6

Effects of mixed oil emulsion on short-term clinical ... SMOF has better lipid tolerance, reduces the incidence of PNAC and MBDP, and exerts more benefits in preterm infants with gestational age < 28 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9608912/

Clinical impact of lipid injectable emulsion in internal ... ILE use was associated with improved clinical outcomes, including lower in-hospital mortality, in internal medicine inpatients receiving parenteral nutrition.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06049680

NCT06049680 | Safety Study of SMOFlipid to Evaluate the ... A Single-arm Open-label Safety Study of SMOFlipid to Evaluate the Risk of Developing Essential Fatty Acid Deficiency (EFAD) and/or Parenteral ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10304446/

Injectable Lipid Emulsion and Clinical Outcomes in ... Guidelines for the nutritional management of critically ill patients recommend the use of injectable lipid emulsion (ILE) as part of parenteral nutrition (PN).

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/207648s005lbl.pdf

SMOFLIPID® (lipid injectable emulsion), for intravenous use The safety and effectiveness of SMOFlipid have been established as a source of calories and essential fatty acids for PN when oral or enteral nutrition is not ...

9. hopkinsmedicine.org hopkinsmedicine.org/-/media/files/allchildrens/clinical-pathways/iv-lipid-emulsions-management-clinical-pathway-5_3_24.pdf

Intravenous Lipid Emulsions Management Clinical Pathway Data suggests that soy-based fat emulsions have been thought to promote cholestasis as they contain predominantly ω-6 long-chain polyunsaturated ...