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CompletedNCT03282955HOMEUpdated Jul 4, 2025Results posted

The HOME Study (HPN With OMEGA-3)

A Phase 4 interventional study of Lipidem and Lipofundin MCT 20% in Patients Requiring Home Parenteral Nutrition, sponsored by B. Braun Melsungen AG. Completed at 9 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-04.

Sponsored by B. Braun Melsungen AG · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Patients Requiring Home Parenteral Nutrition
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 criteria

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
74 participants (actual)

Study arms

  • Experimental
    Lipidem

    i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides)

    Drug: Lipidem

  • Active comparator
    Lipofundin MCT

    i.v. lipid emulsion

    Drug: Lipofundin MCT 20%

Interventions

  • DrugLipidem

    Lipoplus i.v. lipid emulsion for parenteral nutrition

  • DrugLipofundin MCT 20%

    Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

Secondary outcomes

  1. Bilirubin

    Change from baseline

    Time frame: 8 weeks

  2. Alanine Transaminase (ALT)

    Change from baseline

    Time frame: 8 weeks

  3. Aspartate Transaminase (AST)

    Change from baseline

    Time frame: 8 weeks

  4. AST/ALT Ratio

    Change from baseline

    Time frame: 8 weeks

  5. Alkaline Phosphatase (ALP)

    Change from baseline

    Time frame: 8 weeks

  6. Gamma-glutamyl Transpeptidase (GGT)

    Change from baseline

    Time frame: 8 weeks

  7. White Blood Cells (WBCs)

    Change from baseline

    Time frame: 8 weeks

  8. Red Blood Cells (RBCs)

    Change from baseline

    Time frame: 8 weeks

  9. Hemoglobin (Hb)

    Change from baseline

    Time frame: 8 weeks

  10. Platelets

    Change from baseline

    Time frame: 8 weeks

  11. International Normalized Ratio (INR) (if Not Possible Prothrombin Time [PT = Quick-value] is Accepted)

    Change from baseline

    Time frame: 8 weeks

  12. Activated Partial Thromboplastin Time (aPTT)

    Change from baseline

    Time frame: 8 weeks

  13. Hematocrit (Hct)

    Change from baseline

    Time frame: 8 weeks

  14. Blood Glucose

    Change from baseline

    Time frame: 8 weeks

  15. Sodium

    Change from baseline

    Time frame: 8 weeks

  16. Chloride

    Change from baseline

    Time frame: 8 weeks

  17. Potassium

    Change from baseline

    Time frame: 8 weeks

  18. Calcium

    Change from baseline

    Time frame: 8 weeks

  19. Magnesium

    Change from baseline

    Time frame: 8 weeks

  20. Phosphate

    Change from baseline

    Time frame: 8 weeks

  21. Serum Creatinine

    Change from baseline

    Time frame: 8 weeks

  22. Triglycerides

    Change from baseline

    Time frame: 8 weeks

  23. Cholesterol

    Change from baseline

    Time frame: 8 weeks

  24. High-density Lipoprotein (HDL)

    Change from baseline

    Time frame: 8 weeks

  25. Low-density Lipoprotein (LDL)

    Change from baseline

    Time frame: 8 weeks

  26. C-reactive Protein (CRP)

    Change from baseline

    Time frame: 8 weeks

  27. α-Tocopherol/Vitamin E (Facultative if Routinely Assessed)

    Change from baseline

    Time frame: 8 weeks

  28. Triene:Tetraene Ratio in Plasma, Reduction From Baseline

    Derived from fatty acid pattern in plasma

    Time frame: 8 weeks

  29. Adverse Events

    Number of adverse events (including serious adverse events)

    Time frame: 8 weeks

  30. BMI

    Body mass index Change from baseline

    Time frame: 8 weeks

  31. Prothrombin Time (PT)

    Change from baseline

    Time frame: 8 weeks

06

Results

Posted Jul 4, 2025

Participant flow

Participant flow — Overall Study
MilestoneLipidemLipofundin MCT
Started4034
Completed3530
Not completed54

Outcome measures

PrimaryChange 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.

Time frame:
8 weeks
Reported as:
Mean · normalized sum- no unit
Change of Liver Function Parameters From Baseline to Visit 2
normalized sum- no unitLipidemLipofundin MCT
Change of Liver Function Parameters From Baseline to Visit 20.0606 ± 3.0876-0.0703 ± 1.8063
Statistical analysis
  • Lipidem vs Lipofundin MCT · t-test, 1 sided · p = 0.025
SecondaryBilirubin

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · µmol/L
Bilirubin
µmol/LLipidemLipofundin MCT
Bilirubin0.36 ± 3.340.04 ± 3.26
SecondaryAlanine Transaminase (ALT)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · µkat/L
Alanine Transaminase (ALT)
µkat/LLipidemLipofundin MCT
Alanine Transaminase (ALT)0.06 ± 0.600.01 ± 0.25
SecondaryAspartate Transaminase (AST)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · µkat/L
Aspartate Transaminase (AST)
µkat/LLipidemLipofundin MCT
Aspartate Transaminase (AST)-0.03 ± 0.38-0.00 ± 0.21
SecondaryAST/ALT Ratio

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · Ratio
AST/ALT Ratio
RatioLipidemLipofundin MCT
AST/ALT Ratio0.53 ± 1.000.89 ± 2.52
SecondaryAlkaline Phosphatase (ALP)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · µkat/L
Alkaline Phosphatase (ALP)
µkat/LLipidemLipofundin MCT
Alkaline Phosphatase (ALP)0.13 ± 0.66-0.15 ± 1.46
SecondaryGamma-glutamyl Transpeptidase (GGT)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · µkat/L
Gamma-glutamyl Transpeptidase (GGT)
µkat/LLipidemLipofundin MCT
Gamma-glutamyl Transpeptidase (GGT)0.02 ± 0.38-0.11 ± 1.64
SecondaryWhite Blood Cells (WBCs)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · 10^9 cells/L
White Blood Cells (WBCs)
10^9 cells/LLipidemLipofundin MCT
White Blood Cells (WBCs)0.45 ± 1.420.19 ± 1.39
SecondaryRed Blood Cells (RBCs)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · 10^12 cells/L
Red Blood Cells (RBCs)
10^12 cells/LLipidemLipofundin MCT
Red Blood Cells (RBCs)-0.02 ± 0.28-0.10 ± 0.28
SecondaryHemoglobin (Hb)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · g/L
Hemoglobin (Hb)
g/LLipidemLipofundin MCT
Hemoglobin (Hb)0.52 ± 8.82-1.75 ± 8.22
SecondaryPlatelets

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · 10^9 cells/L
Platelets
10^9 cells/LLipidemLipofundin MCT
Platelets3.06 ± 41.116.90 ± 50.33
SecondaryInternational Normalized Ratio (INR) (if Not Possible Prothrombin Time [PT = Quick-value] is Accepted)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · Ratio
International Normalized Ratio (INR) (if Not Possible Prothrombin Time [PT = Quick-value] is Accepted)
RatioLipidemLipofundin MCT
International Normalized Ratio (INR) (if Not Possible Prothrombin Time [PT = Quick-value] is Accepted)-0.01 ± 0.25-0.16 ± 0.71
SecondaryActivated Partial Thromboplastin Time (aPTT)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · seconds
Activated Partial Thromboplastin Time (aPTT)
secondsLipidemLipofundin MCT
Activated Partial Thromboplastin Time (aPTT)0.02 ± 3.850.97 ± 7.69
SecondaryHematocrit (Hct)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · L/L
Hematocrit (Hct)
L/LLipidemLipofundin MCT
Hematocrit (Hct)-0.00 ± 0.03-0.01 ± 0.03
SecondaryBlood Glucose

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
Blood Glucose
mmol/LLipidemLipofundin MCT
Blood Glucose0.43 ± 0.94-0.14 ± 1.33
SecondarySodium

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
Sodium
mmol/LLipidemLipofundin MCT
Sodium0.18 ± 2.67-0.58 ± 2.74
SecondaryChloride

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
Chloride
mmol/LLipidemLipofundin MCT
Chloride-0.19 ± 3.33-0.15 ± 4.08
SecondaryPotassium

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
Potassium
mmol/LLipidemLipofundin MCT
Potassium0.06 ± 0.370.01 ± 0.46
SecondaryCalcium

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
Calcium
mmol/LLipidemLipofundin MCT
Calcium-0.01 ± 0.15-0.01 ± 0.10
SecondaryMagnesium

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
Magnesium
mmol/LLipidemLipofundin MCT
Magnesium0.00 ± 0.09-0.00 ± 0.06
SecondaryPhosphate

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
Phosphate
mmol/LLipidemLipofundin MCT
Phosphate-0.02 ± 0.18-0.00 ± 0.16
SecondarySerum Creatinine

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · µmol/L
Serum Creatinine
µmol/LLipidemLipofundin MCT
Serum Creatinine3.87 ± 32.420.43 ± 9.23
SecondaryTriglycerides

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
Triglycerides
mmol/LLipidemLipofundin MCT
Triglycerides0.10 ± 0.550.19 ± 0.68
SecondaryCholesterol

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
Cholesterol
mmol/LLipidemLipofundin MCT
Cholesterol0.01 ± 0.390.02 ± 0.71
SecondaryHigh-density Lipoprotein (HDL)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
High-density Lipoprotein (HDL)
mmol/LLipidemLipofundin MCT
High-density Lipoprotein (HDL)-0.12 ± 0.190.03 ± 0.23
SecondaryLow-density Lipoprotein (LDL)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · mmol/L
Low-density Lipoprotein (LDL)
mmol/LLipidemLipofundin MCT
Low-density Lipoprotein (LDL)0.07 ± 0.33-0.08 ± 0.76
SecondaryC-reactive Protein (CRP)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · nmol/L
C-reactive Protein (CRP)
nmol/LLipidemLipofundin MCT
C-reactive Protein (CRP)37.16 ± 160.03-24.65 ± 209.18
Secondaryα-Tocopherol/Vitamin E (Facultative if Routinely Assessed)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · µmol/L]
α-Tocopherol/Vitamin E (Facultative if Routinely Assessed)
µmol/L]LipidemLipofundin MCT
α-Tocopherol/Vitamin E (Facultative if Routinely Assessed)-3.00 ± 6.60-1.94 ± 10.99
SecondaryTriene:Tetraene Ratio in Plasma, Reduction From Baseline

Derived from fatty acid pattern in plasma

Time frame:
8 weeks
Reported as:
Mean · Ratio
Triene:Tetraene Ratio in Plasma, Reduction From Baseline
RatioLipidemLipofundin MCT
Triene:Tetraene Ratio in Plasma, Reduction From Baseline0.011 ± 0.0240.008 ± 0.028
SecondaryAdverse Events

Number of adverse events (including serious adverse events)

Time frame:
8 weeks
Reported as:
Number · Adverse events
Adverse Events
Adverse eventsLipidemLipofundin MCT
Adverse Events3125
SecondaryBMI

Body mass index Change from baseline

Time frame:
8 weeks
Reported as:
Mean · kg/m^2
BMI
kg/m^2LipidemLipofundin MCT
BMI0.4 ± 0.70.2 ± 0.7
SecondaryProthrombin Time (PT)

Change from baseline

Time frame:
8 weeks
Reported as:
Mean · s
Prothrombin Time (PT)
sLipidemLipofundin MCT
Prothrombin Time (PT)-0.8 ± 1.151.27 ± 5.16

Adverse events

Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lipidem0/40 (0%)5/40 (12.5%)15/40 (37.5%)
Lipofundin MCT0/34 (0%)3/34 (8.8%)12/34 (35.3%)
Most frequent serious events
Most frequent serious events
EventLipidemLipofundin MCT
Device related infectionInfections and infestations1/402/34
Abdominal painGastrointestinal disorders0/401/34
Device dislocatioinProduct Issues0/401/34
Intestinal pseudo-obstructionGastrointestinal disorders0/401/34
Stoma site infectionInfections and infestations1/400/34
AnaemiaBlood and lymphatic system disorders1/400/34
Device breakageProduct Issues1/400/34
Dermo-hypodermitisInfections and infestations1/400/34
Most frequent other events
Showing 10 of 37
Most frequent other events
EventLipidemLipofundin MCT
Alanine Aminotransferase increasedInvestigations3/400/34
DiarrhoeaGastrointestinal disorders3/400/34
InfluenzaInfections and infestations0/402/34
NasopharyngitisInfections and infestations0/402/34
HeadacheNervous system disorders1/401/34
ArthralgiaMusculoskeletal and connective tissue disorders0/401/34
LymphangitisInfections and infestations0/401/34
Back painMusculoskeletal and connective tissue disorders0/401/34
ParesthesiaNervous system disorders0/401/34
FatigueGeneral disorders0/401/34

Baseline characteristics

74 patients were enrolled for the study. However, 2 patients dropped out before any further intervention. Therefor these 2 patients were not included in the baseline analysis population.

Age, Continuous
Age, Continuous(years)LipidemLipofundin MCTTotal
Mean50.13 ± 15.8252.44 ± 15.5051.22 ± 15.60
Sex: Female, Male
Sex: Female, Male(Participants)LipidemLipofundin MCTTotal
Female162440
Male221032
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)LipidemLipofundin MCTTotal
White353166
Black or African American101
Native Hawaiian/Other Pacific011
Missing224
Region of Enrollment
Region of Enrollment(participants)LipidemLipofundin MCTTotal
Netherlands437
Poland201636
Italy235
United Kingdom213
France101121
07

Study locations

9 sites
  • Hôpital Archet 2 - Unité de support nutritionnel
    Nice, France
  • Hospices Civiles de Lyon - Centre hospitalier Lyon Sud
    Pierre-Bénite, France
  • Department of Medical and Surgical Science, University of Bologna, Center for Chronic Intestinal Failure, Department of Digestive System, St. Orsola-Malpighi Hospital
    Bologna, Italy
  • Radboud university medical center
    Nijmegen, Netherlands
  • Wojewódzkim Specjalistycznym Szpitalem im. M. Pirogowa w Łodzi , Oddział Chirurgii Ogólnej i Naczyniowej
    Lodz, Poland
  • Stanley Dudrick's Memorial Hospital
    Skawina, Poland
  • Samodzielny Publiczny Szpital Kliniczny, im. prof. dr W. Orlowskiego, Centrum Medycznego Ksztalcenia Podyplomowego, Oddzial Kliniczny Zywienia i Chirurgii
    Warsaw, Poland
  • University Hospitals Birmingham NHS Foundation Trust
    Birmingham, United Kingdom
  • University College Hospital London
    London, United Kingdom
08

References and documents

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. PubMed 39581180 ↗
  • 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. PubMed 31888740 ↗

Study documents

  • Protocol and statistical analysis plan · May 21, 2021

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03282955
Lead sponsor
B. Braun Melsungen AG
Responsible party
Sponsor
First posted
Sep 14, 2017
Start date
Jan 8, 2018
Primary completion
Jul 19, 2022
Completion
Jul 19, 2022
Results posted
Jul 4, 2025
Last update
Jul 4, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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