Home parenteral nutrition with an omega-3 fatty acid enriched MCT/LCT lipid emulsion in patients with chronic intestinal failure (the HOME study): Study protocol for a randomized, controlled, multicenter, international clinical trial

Abstract Background Home parenteral nutrition (HPN) is a life-preserving therapy for patients with chronic intestinal failure (CIF) indicated for patients who cannot achieve their nutritional requirements by enteral intake. Intravenously administered lipid emulsions (ILEs) are an essential component of HPN, providing energy and essential fatty acids, but can become a risk factor for intestinal-failure-associated liver disease (IFALD). In HPN patients, major effort is taken in the prevention of IFALD. Novel ILEs containing a proportion of omega-3 polyunsaturated fatty acids (n-3 PUFA) could be of benefit, but the data on the use of n-3 PUFA in HPN patients are still limited. Methods/design The HOME study is a prospective, randomized, controlled, double-blind, multicenter, international clinical trial conducted in European hospitals that treat HPN patients. A total of 160 patients (80 per group) will be randomly assigned to receive the n-3 PUFA-enriched medium/long-chain triglyceride (MCT/LCT) ILE (Lipidem/Lipoplus® 200 mg/ml, B. Braun Melsungen AG) or the MCT/LCT ILE (Lipofundin® MCT/LCT/Medialipide® 20%, B. Braun Melsungen AG) for a projected period of 8 weeks. The primary endpoint is the combined change of liver function parameters (total bilirubin, aspartate transaminase and alanine transaminase) from baseline to final visit. Secondary objectives are the further evaluation of the safety and tolerability as well as the efficacy of the ILEs. Discussion Currently, there are only very few randomized controlled trials (RCTs) investigating the use of ILEs in HPN, and there are very few data at all on the use of n-3 PUFAs. The working hypothesis is that n-3 PUFA-enriched ILE is safe and well-tolerated especially with regard to liver function in patients requiring HPN. The expected outcome is to provide reliable data to support this thesis thanks to a considerable number of CIF patients, consequently to broaden the present evidence on the use of ILEs in HPN. Trial registration ClinicalTrials.gov, ID: NCT03282955. Registered on 14 September 2017.

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Home parenteral nutrition with an omega-3 fatty acid enriched MCT/LCT lipid emulsion in patients with chronic intestinal failure (the HOME study): Study protocol for a randomized, controlled, multicenter, international clinical trial

10.21203/rs.2.15196/v1 ◽

2019 ◽

Author(s):

Stanislaw Klek ◽

Cecile Chambrier ◽

Sheldon C Cooper ◽

Simon Gabe ◽

Marek Kunecki ◽

...

Keyword(s):

Clinical Trial ◽

Fatty Acids ◽

Liver Function ◽

Parenteral Nutrition ◽

Intestinal Failure ◽

Home Parenteral Nutrition ◽

Omega 3 ◽

Home Study ◽

Randomized Controlled ◽

International Clinical Trial

Abstract Background Home parenteral nutrition (HPN) is a life-preserving therapy for patients with chronic intestinal failure (CIF) indicated for patients who cannot achieve their nutritional requirements by enteral intake. Intravenous lipid emulsions (ILEs) are an essential component of HPN providing energy and essential fatty acids, but can become a risk factor for intestinal failure-associated liver disease (IFALD). In HPN patients, major effort is taken in the prevention of IFALD. Novel ILEs containing a proportion of omega-3 polyunsaturated fatty acids (n-3 PUFA) could be of benefit, but the data on the use of n-3 PUFA in HPN patients are still limited.Methods The HOME study is a prospective, randomized, controlled, double-blind, multicenter, international clinical trial conducted in European hospitals that treat HPN patients. A total of 160 patients (80 per group) will be randomly assigned to receive the n-3 PUFA enriched medium/long-chain triglyceride (MCT/LCT) ILE (Lipidem / Lipoplus ® 200 mg/ml, B. Braun Melsungen AG) or the MCT/LCT ILE (Lipofundin ® MCT/LCT / Medialipide ® 20%, B. Braun Melsungen AG) for a projected period of eight weeks. The primary endpoint is the combined change of liver function parameters (total bilirubin, aspartate transaminase and alanine transaminase) from baseline to final visit. Secondary objectives are the further evaluation of safety and tolerability as well as the efficacy of the ILEs.Discussion Currently, there are only very few randomized controlled trials (RCTs) investigating the use of ILEs in HPN, and there are very few data at all on the use of n-3 PUFAs. The aim of the HOME study is to demonstrate that the n-3 PUFA enriched ILE is safe and well tolerated especially with regard to liver function in patients requiring HPN. The study will provide data from a considerable number of CIF patients and thus contribute to broaden the present evidence on the use of ILEs in HPN.Trial registrationClinicalTrials.gov, NCT03282955, registered on September 14, 2017

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Supplemental parenteral nutrition enriched with omega-3 polyunsaturated fatty acids in intensive care patients – a randomized, controlled, double-blind clinical trial

Clinical Nutrition ESPEN ◽

10.1016/j.clnesp.2021.09.073 ◽

2021 ◽

Vol 46 ◽

pp. S565

Author(s):

P. Singer ◽

R. Mesalati-Stahzi ◽

I. Bendavid ◽

M. Theilla ◽

A. Ariel ◽

...

Keyword(s):

Clinical Trial ◽

Fatty Acids ◽

Intensive Care ◽

Parenteral Nutrition ◽

Polyunsaturated Fatty Acids ◽

Omega 3 ◽

Double Blind ◽

Intensive Care Patients ◽

Randomized Controlled ◽

Double Blind Clinical Trial

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Enteral and supplemental parenteral nutrition enriched with omega-3 polyunsaturated fatty acids in intensive care patients – A randomized, controlled, double-blind clinical trial

Clinical Nutrition ◽

10.1016/j.clnu.2021.03.034 ◽

2021 ◽

Vol 40 (5) ◽

pp. 2544-2554

Author(s):

Pierre Singer ◽

Itai Bendavid ◽

Ronit Mesilati-Stahy ◽

Pnina Green ◽

Merav Rigler ◽

...

Keyword(s):

Clinical Trial ◽

Fatty Acids ◽

Intensive Care ◽

Parenteral Nutrition ◽

Polyunsaturated Fatty Acids ◽

Omega 3 ◽

Double Blind ◽

Intensive Care Patients ◽

Randomized Controlled ◽

Double Blind Clinical Trial

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MON-P074: Parenteral Olive Oil Improves Liver Function in Intestinal Failure Patients: Randomized, Controlled Clinical Trial

Clinical Nutrition ◽

10.1016/s0261-5614(17)31009-9 ◽

2017 ◽

Vol 36 ◽

pp. S207

Author(s):

S. Klek ◽

K. Szczepanek ◽

L. Scislo ◽

E. Walewska ◽

M. Pietka ◽

...

Keyword(s):

Clinical Trial ◽

Liver Function ◽

Olive Oil ◽

Intestinal Failure ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Randomized Controlled

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Intravenous lipid emulsions and liver function in adult chronic intestinal failure patients: Results after 5 y of home parenteral nutrition

Nutrition ◽

10.1016/j.nut.2020.111029 ◽

2020 ◽

pp. 111029

Author(s):

Stanislaw Klek ◽

Kinga Szczepanek ◽

Lucyna Scislo ◽

Elzbieta Walewska ◽

Magdalena Pietka ◽

...

Keyword(s):

Liver Function ◽

Parenteral Nutrition ◽

Intestinal Failure ◽

Home Parenteral Nutrition ◽

Lipid Emulsions

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A Randomized Controlled Clinical Trial Investigating the Effects of Omega-3 Fatty Acids and Vitamin E Co-Supplementation on Biomarkers of Oxidative Stress, Inflammation and Pregnancy Outcomes in Gestational Diabetes

Canadian Journal of Diabetes ◽

10.1016/j.jcjd.2016.09.004 ◽

2017 ◽

Vol 41 (2) ◽

pp. 143-149 ◽

Cited By ~ 22

Author(s):

Mehri Jamilian ◽

Shahrzad Hashemi Dizaji ◽

Fereshteh Bahmani ◽

Mohsen Taghizadeh ◽

Mohammad Reza Memarzadeh ◽

...

Keyword(s):

Oxidative Stress ◽

Clinical Trial ◽

Fatty Acids ◽

Pregnancy Outcomes ◽

Controlled Clinical Trial ◽

Omega 3 Fatty Acids ◽

Omega 3 ◽

Randomized Controlled Clinical Trial ◽

Randomized Controlled ◽

Biomarkers Of Oxidative Stress

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Intravenous Lipid Emulsions in Infants: Is Balanced Better?

Neonatal Network The Journal of Neonatal Nursing ◽

10.1891/0730-0832.38.1.39 ◽

2019 ◽

Vol 38 (1) ◽

pp. 39-45 ◽

Cited By ~ 1

Author(s):

Sara E. Rostas ◽

Christopher McPherson

Keyword(s):

Fatty Acids ◽

Parenteral Nutrition ◽

Neonatal Intensive Care ◽

Intestinal Failure ◽

Lipid Emulsions ◽

Omega 3 Fatty Acids ◽

Omega 3 ◽

Extremely Preterm ◽

Extremely Preterm Infants ◽

Omega 6

Parenteral nutrition (PN) is frequently required by extremely preterm infants due to gastrointestinal immaturity and complications of prematurity. Parenteral nutrition-associated cholestasis (PNAC) and intestinal failure-associated liver disease (IFALD) are common complications of prolonged PN. Plant-based intravenous lipid emulsions, containing proinflammatory omega-6 fatty acids and phytosterols, may contribute to these conditions as well as other comorbidities such as bronchopulmonary dysplasia and retinopathy of prematurity. Intravenous lipid emulsions containing animal-based fats, such as fish oil, contain fewer proinflammatory omega-6 fatty acids and more anti-inflammatory omega-3 fatty acids and antioxidants. SMOFlipid, recently Food and Drug Administration (FDA)-approved for adult use, is a blend of plant- and animal-based lipid emulsions with a favorable omega-6:omega-3 ratio that may prevent the development and progression of PNAC/IFALD in infants. Careful review of data supporting this alternative intravenous lipid emulsion is required prior to widespread use in neonatal intensive care.

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