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

Trial Summary

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 data supports the effectiveness of the drug SMOFlipid for treating malnutrition?

Research shows that SMOFlipid, a mix of oils like soybean, olive, and fish oil, is effective in providing essential nutrients and energy, especially in children and surgical patients who need nutrition through an IV. It has been shown to improve fatty acid levels and liver function in patients with intestinal issues. ^{1 2 3 4 5}

Is SMOFlipid safe for humans?

SMOFlipid, a type of intravenous fat emulsion, has been studied for safety in various groups, including children and surgical patients. Research indicates that serious side effects are rare, although there have been isolated reports of issues like pulmonary lipid emboli (blockages in the lungs caused by fat particles) with long-term use. ^{1 2 3 4 5}

How is the drug SMOFlipid different from other treatments for malnutrition?

SMOFlipid is unique because it is an intravenous lipid emulsion that combines soybean oil, medium-chain triglycerides, olive oil, and fish oil, providing a mix of essential fatty acids and long-chain omega-3 fatty acids. This combination aims to improve energy supply and nutritional status, which may offer benefits over traditional soybean oil-based emulsions. ^{1 2 3 4 6}

What is the purpose of this trial?

Evaluate the risk of developing EFAD and/or PNAC in adult and pediatric patients 1 month of age and older, who are anticipated to need 8 weeks or longer of parenteral nutrition treatment with SMOFlipid.

Research Team

Jeffrey Rudolph, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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 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 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]

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]

References

1. England 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. [2022]

2. United States 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. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a new parenteral lipid emulsion (SMOFlipid) in surgical patients: a randomized, double-blind, multicenter study. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of SMOFlipid in Pediatric Intestinal-Failure Patients and Its Effects on Essential Fatty Acid Levels. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Pulmonary lipid emboli in association with long-term hyperalimentation. [2019]

6. United States 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. [2018]