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. 2019 Dec 30;20(1):808.
doi: 10.1186/s13063-019-3994-z.

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

Stanislaw Klek  1 , Cécile Chambrier  2 , Sheldon C Cooper  3 , Simon Gabe  4 , Marek Kunecki  5 , Loris Pironi  6 , Farooq Rahman  7 , Jacek Sobocki  8 , Kinga Szczepanek  9 , Geert Wanten  10 , Nicole Lincke  11 , Bernhard Glotzbach  11 , Alastair Forbes  12
Affiliations

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

Stanislaw Klek et al. Trials. .

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.

Keywords: Chronic intestinal failure; Home parenteral nutrition; Intravenous lipid emulsion; Liver function; Omega-3 PUFA; Randomized controlled trial.

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Conflict of interest statement

SK received honoraria as a lecturer from Baxter, BBraun, Fresenius-Kabi, Nestle, Nutricia and Shire. CC declares conflicting interests with Baxter and BBraun. SC received educational sponsorship from Fresenius-Kabi/Calea and Shire/Takeda and honoraria from Baxter and Novartis. SG received consultancy honoraria and funding for conferences from Takeda and Shire. MK received honoraria as a speaker from Baxter, Fresenius-Kabi, and Shire. LP received an advisory board grant from Baxter, Fresenius-Kabi and Shire, and an educational grant from SEDA. FR declares that he has no competing interests. JS received honoraria as a lecturer from Baxter, BBraun, Fresenius-Kabi, Nestle, Nutricia and Shire. KS received honoraria as a lecturer from Baxter, BBraun, Fresenius-Kabi and Nutricia. GW received research grants from Fresenius-Kabi, Baxter, BBraun and Geistlich Pharma. AF is a member of the speakers’ bureau for Baxter, BBraun, Dr Falk Pharma, and Fresenius-Kabi. NL and BG are employed by B. Braun Melsungen AG.

Figures

Fig. 1
Fig. 1
Standard Protocol Items: Recommendations for Interventional Trial (SPIRIT) Figure: HOME study visits. 1The parenteral nutrition (PN) treatment including Investigational Product (IP) will be prescribed until the final visit. If applicable, changes in prescription will be documented continuously throughout the course of the study. 2No blood samples for central laboratory analysis of fatty acid pattern in red blood cells and plasma will be taken
See this image and copyright information in PMC

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