Journal Article

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

Klek, Stanislaw, Cooper, Sheldon C., Pironi, Loris, Sobocki, Jacek, Glotzbach, Bernhard, Kunecki, Marek, Chambrier, Cécile, Wanten, Geert, Lincke, Nicole, Szczepanek, Kinga, Rahman, Farooq, Forbes, Alastair, Gabe, Simon

2019

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adolescent / Adult / Aged / Aged, 80 and over / Alanine Transaminase - blood / Aspartate / Aspartate Aminotransferases - blood / Bilirubin / Bilirubin - blood / Biomedicine / Chronic intestinal failure / Clinical trials / Contraindications / Double-Blind Method / Drug Combinations / Fat Emulsions, Intravenous - adverse effects / Fat Emulsions, Intravenous - therapeutic use / Fatty acids / Fatty Acids, Omega-3 - administration & dosage / Female / Health Sciences / Home parenteral nutrition / Hospitals / Human nutrition / Humans / Intravenous lipid emulsion / Lipids / Liver / Liver diseases / Liver function / Liver Function Tests - methods / Malabsorption Syndromes - blood / Malabsorption Syndromes - therapy / Male / Medical records / Medicine / Medicine & Public Health / Metabolism / Metabolites / Middle Aged / Multicenter Studies as Topic / Nutrition / Nutritional requirements / Omega-3 fatty acids / Omega-3 PUFA / Parenteral nutrition / Parenteral Nutrition, Home - methods / Participation / Patients / Phospholipids - adverse effects / Phospholipids - therapeutic use / Polyunsaturated fatty acids / Prospective Studies / Randomized controlled trial / Randomized Controlled Trials as Topic / Sorbitol - adverse effects / Sorbitol - therapeutic use / Statistics for Life Sciences / Study Protocol / Treatment Outcome / Triglycerides / Triglycerides - administration & dosage / Unsaturated fatty acids / Young Adult