The HOME Study (HPN With OMEGA-3) (HOME)

A Randomized, Controlled, Double-blind, Multicenter Clinical Trial on Home Parenteral Nutrition Using an Omega-3 Fatty Acid Enriched MCT/LCT Lipid Emulsion

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.

Study Overview

• Status: Completed
• Conditions: Patients Requiring Home Parenteral Nutrition
• Intervention / Treatment: Drug: Lipidem; Drug: Lipofundin MCT 20%

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Nice, France
    • Hôpital Archet 2 - Unité de support nutritionnel
  • Pierre-Bénite, France
    • Hospices Civiles de Lyon - Centre hospitalier Lyon Sud
• Italy
  • Bologna, Italy
    • Department of Medical and Surgical Science, University of Bologna, Center for Chronic Intestinal Failure, Department of Digestive System, St. Orsola-Malpighi Hospital
• Netherlands
  • Nijmegen, Netherlands
    • Radboud University Medical Center
• Poland
  • Skawina, Poland
    • Stanley Dudrick's Memorial Hospital
  • Warszawa, Poland
    • Samodzielny Publiczny Szpital Kliniczny, im. prof. dr W. Orlowskiego, Centrum Medycznego Ksztalcenia Podyplomowego, Oddzial Kliniczny Zywienia i Chirurgii
  • Łódź, Poland
    • Wojewódzkim Specjalistycznym Szpitalem im. M. Pirogowa w Łodzi , Oddział Chirurgii Ogólnej i Naczyniowej
• United Kingdom
  • Birmingham, United Kingdom
    • University Hospitals Birmingham NHS Foundation Trust
  • London, United Kingdom
    • University College Hospital London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion:

• Signed informed consent available
• Male or female patients ≥ 18 years of age
• Patients with chronic intestinal failure receiving HPN including lipids in whom the parenteral macronutrients have not been changed by more than 10% for at least 3 months
• Patients receiving ≥ 3.0 g lipids/kg body weight per week

Exclusion:

• Persistent high total bilirubin values in medical history of last 6 months (> 40µmol/l)
• Patients in whom PN was interrupted for longer than 4 continuous weeks in the preceding 6 months
• Patients with history of cancer and anti-cancer treatment within the last 2 years
• Hypersensitivity to egg, fish, peanut or soya-bean protein or to any of the active substances or excipients
• Patients treated in the past or currently with Teduglutide

• Contraindications to investigational products (if available from medical records) including:

  • Severe hyperlipidemia, including severe hypertriglyceridaemia (≥1000 mg/dl or 11.4 mmol/l)
  • Severe coagulopathy
  • Intrahepatic cholestasis
  • Severe hepatic insufficiency
  • Severe renal insufficiency in absence of renal replacement therapy
  • Acute thromboembolic events
  • Fat embolism
  • Aggravating haemorrhagic diatheses
  • Metabolic acidosis

• General contraindications to parenteral nutrition (if available from medical records) including:

  • Unstable circulatory status with vital threat (states of collapse and shock)
  • Acute phase of cardiac infarction or stroke
  • Unstable metabolic conditions (e.g. decompensated diabetes mellitus, severe sepsis, coma of unknown origin)
  • Inadequate cellular oxygen supply
  • Disturbances of the electrolyte and fluid balance (e.g. hypokalaemia and hypotonic dehydration)
  • Acute pulmonary edema
  • Decompensated cardiac insufficiency
• Positive test for HIV, Hepatitis B or C (from medical history)
• Known or suspected drug or alcohol abuse
• Patients who are unwilling or mentally and/or physically unable to adhere to study procedures
• Participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial
• Any medical condition that in the opinion of the investigator might put the subject at risk or interfere with patients participation For women with childbearing potential (i.e. females who are not chemically or surgically sterile or females who are not post-menopausal)
• Women of childbearing potential tested positive on standard pregnancy test (urine dipstick)
• Lactation
• Women of childbearing potential who do not agree to apply adequate contraception
• Persons of legal age who are the subject of a legal protection measure or who are unable to express their consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lipidem; i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides)	Drug: Lipidem; Lipoplus i.v. lipid emulsion for parenteral nutrition
Active Comparator: Lipofundin MCT; i.v. lipid emulsion	Drug: Lipofundin MCT 20%; Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Liver Function Parameters From Baseline to Visit 2	Changes will be expressed as the sum of the N(0.1)- transformed differences of bilirubin, ALT and AST (from Baseline to Visit 2), i.e. for all three parameters each change of the value is subtracted by the mean change of the respective parameter. This difference is divided by the standard deviation of the change, which results in a unitless normalised value. All values for the 3 liver parameters (bilirubin, ALT and AST) will be added. The final sum reflects the change of liver function parameters.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bilirubin	Change from baseline	8 weeks
Alanine Transaminase (ALT)	Change from baseline	8 weeks
Aspartate Transaminase (AST)	Change from baseline	8 weeks
AST/ALT Ratio	Change from baseline	8 weeks
Alkaline Phosphatase (ALP)	Change from baseline	8 weeks
Gamma-glutamyl Transpeptidase (GGT)	Change from baseline	8 weeks
White Blood Cells (WBCs)	Change from baseline	8 weeks
Red Blood Cells (RBCs)	Change from baseline	8 weeks
Hemoglobin (Hb)	Change from baseline	8 weeks
Platelets	Change from baseline	8 weeks
International Normalized Ratio (INR) (if Not Possible Prothrombin Time [PT = Quick-value] is Accepted)	Change from baseline	8 weeks
Activated Partial Thromboplastin Time (aPTT)	Change from baseline	8 weeks
Hematocrit (Hct)	Change from baseline	8 weeks
Blood Glucose	Change from baseline	8 weeks
Sodium	Change from baseline	8 weeks
Chloride	Change from baseline	8 weeks
Potassium	Change from baseline	8 weeks
Calcium	Change from baseline	8 weeks
Magnesium	Change from baseline	8 weeks
Phosphate	Change from baseline	8 weeks
Serum Creatinine	Change from baseline	8 weeks
Triglycerides	Change from baseline	8 weeks
Cholesterol	Change from baseline	8 weeks
High-density Lipoprotein (HDL)	Change from baseline	8 weeks
Low-density Lipoprotein (LDL)	Change from baseline	8 weeks
C-reactive Protein (CRP)	Change from baseline	8 weeks
α-Tocopherol/Vitamin E (Facultative if Routinely Assessed)	Change from baseline	8 weeks
Triene:Tetraene Ratio in Plasma, Reduction From Baseline	Derived from fatty acid pattern in plasma	8 weeks
Adverse Events	Number of adverse events (including serious adverse events)	8 weeks
BMI	Body mass index Change from baseline	8 weeks
Prothrombin Time (PT)	Change from baseline	8 weeks

Collaborators and Investigators

• Sponsor: B. Braun Melsungen AG

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Actual): July 19, 2022
• Study Completion (Actual): July 19, 2022

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (Actual): September 14, 2017

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HC-G-H-1403

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No