The HOME Study (HPN With OMEGA-3)

Summary

The aim of the trial is to investigate safety and tolerability of an Omega-3-FA-enriched lipid emulsion in adult patients with chronic intestinal failure in need of long-term HPN. It is aimed to show non-inferiority of the lipid emulsion Lipidem (investigational test product) in comparison to the lipid emulsion Lipofundin MCT (investigational reference product) with regard to liver function.

Timeline

Start

2018-01-08

Primary completion

2022-07-19

Completion

2022-07-19

Outcome

Met primary endpoint

registry analysis (non-inferiority test); Lipidem vs Lipofundin MCT; p = 0.025; t-test, 1 sided NCT03282955 ↗

paper Liver function parameters showed no clinically relevant differences between study groups and remained within normal ranges. PMID 39581180 ↗

Publications

• Klek S, Chambrier C, Szczepanek K, Kunecki M, Sobocki J, Wanten G, Pironi L, Schneider SM, Rahman F, Cooper SC, Calder PC, Gabe S, Forbes A. Safe and well-tolerated long-term parenteral nutrition regimen: Omega-3-fatty-acid-enriched medium chained/ long chained triglycerides emulsion. Clin Nutr. 2024 Dec;43(12):415-424. doi: 10.1016/j.clnu.2024.11.007. Epub 2024 Nov 7.
• Klek S, Chambrier C, Cooper SC, Gabe S, Kunecki M, Pironi L, Rahman F, Sobocki J, Szczepanek K, Wanten G, Lincke N, Glotzbach B, Forbes A. 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. Trials. 2019 Dec 30;20(1):808. doi: 10.1186/s13063-019-3994-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lipidem	Other / unclassified	200 mg/ml	Intravenous
Comparator	Lipofundin MCT	Other / unclassified	20 %	Intravenous

Indications

No indication recorded.