Patients Requiring Home Parenteral NutritionPhase 4HOMENCT03282955

The HOME Study (HPN With OMEGA-3)

A Phase 4 study testing Lipidem and Lipofundin MCT 20% in people with Patients Requiring Home Parenteral Nutrition, run by B. Braun Melsungen AG at 9 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Patients Requiring Home Parenteral Nutrition
What is being tested?: Lipidem and Lipofundin MCT 20%
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 9 sitesin 5 countries
Study dates: 8 Jan 2018to 19 Jul 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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:

Show all 32Show fewer

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

Trial locations and contacts

9 sites in 5 countries.

Country

City, postcode or hospital

9 sites in 5 countries

Poland3 sites

Wojewódzkim Specjalistycznym Szpitalem im. M. Pirogowa w Łodzi , Oddział Chirurgii Ogólnej i Naczyniowej
Lodz
Stanley Dudrick's Memorial Hospital
Skawina
Samodzielny Publiczny Szpital Kliniczny, im. prof. dr W. Orlowskiego, Centrum Medycznego Ksztalcenia Podyplomowego, Oddzial Kliniczny Zywienia i Chirurgii
Warsaw

Other trials in Poland

France2 sites

Hôpital Archet 2 - Unité de support nutritionnel
Nice
Hospices Civiles de Lyon - Centre hospitalier Lyon Sud
Pierre-Bénite

Other trials in France

United Kingdom2 sites

University Hospitals Birmingham NHS Foundation Trust
Birmingham
University College Hospital London
London

Other trials in United Kingdom

Italy1 site

Department of Medical and Surgical Science, University of Bologna, Center for Chronic Intestinal Failure, Department of Digestive System, St. Orsola-Malpighi Hospital
Bologna

Other trials in Italy

Netherlands1 site

Radboud university medical center
Nijmegen

Other trials in Netherlands

About this study

Official title: 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.

Conditions: Patients Requiring Home Parenteral Nutrition
Being tested: Lipidem, Lipofundin MCT 20%

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03282955
Study group	Role	What they receive
Lipidem	Experimental	i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides) Receives: Drug: Lipidem
Lipofundin MCT	Active comparator	i.v. lipid emulsion Receives: Drug: Lipofundin MCT 20%

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 8 weeks

Secondary outcomes (31)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jan 201819 Jul 2022

First posted14 Sep 2017
Study start8 Jan 2018
Primary completion19 Jul 2022
Study completion19 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Patients Requiring Home Parenteral NutritionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03282955
Sponsor's protocol ID: HC-G-H-1403
Acronym: HOME
Status last verified: Jun 2025
First submitted: 10 Aug 2017
Last updated: 4 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

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 at a glance

From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled, Double-blind, Multicenter Clinical Trial on Home Parenteral Nutrition Using an Omega-3 Fatty Acid Enriched MCT/LCT Lipid Emulsion
ClinicalTrials.gov ID: NCT03282955
Acronym / sponsor ID: HOME / HC-G-H-1403
Conditions: Patients Requiring Home Parenteral Nutrition
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: B. Braun Melsungen AGIndustry (pharma, biotech, devices)
Study start: 8 Jan 2018 (actual)
Primary completion: 19 Jul 2022 (actual)
Study completion: 19 Jul 2022 (actual)
First posted: 14 Sep 2017 (actual)
Results: Posted 4 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Lipidem	Experimental	Drug: Lipidemi.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides)
Lipofundin MCT	Active comparator	Drug: Lipofundin MCT 20%i.v. lipid emulsion

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (32 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LipidemLipoplus i.v. lipid emulsion for parenteral nutrition	Drug	Lipidem
Lipofundin MCT 20%Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition	Drug	Lipofundin MCT

Primary outcome

Change of Liver Function Parameters From Baseline to Visit 2
Time frame: 8 weeks
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.

31 secondary outcomes

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

Results and safety

Results posted to the registry on 4 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lipidem	40	35
Lipofundin MCT	34	30

Primary outcome: Change of Liver Function Parameters From Baseline to Visit 2

Time frame: 8 weeks. Mean (Standard Deviation). Unit: normalized sum- no unit

Measure	Lipidem n = 36	Lipofundin MCT n = 31
Value	0.0606 (3.0876)	-0.0703 (1.8063)

Lipidem vs Lipofundin MCT: p = 0.025, t-test, 1 sided

Population analysed: Full Analysis Set

31 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lipidem	5 of 40 (12.5%)	15 of 40 (37.5%)	0 of 40
Lipofundin MCT	3 of 34 (8.8%)	12 of 34 (35.3%)	0 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39581180Klek 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.
Derived from this study: PubMed 31888740Klek 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

9 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lipidem and Lipofundin MCT 20% in people with Patients Requiring Home Parenteral Nutrition, run by B. Braun Melsungen AG at 9 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Poland, France, United Kingdom, Italy, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Liver Function Parameters From Baseline to Visit 2 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03282955, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.