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

June 11, 2025 updated by: B. Braun Melsungen AG

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bilirubin
Time Frame: 8 weeks
Change from baseline
8 weeks
Alanine Transaminase (ALT)
Time Frame: 8 weeks
Change from baseline
8 weeks
Aspartate Transaminase (AST)
Time Frame: 8 weeks
Change from baseline
8 weeks
AST/ALT Ratio
Time Frame: 8 weeks
Change from baseline
8 weeks
Alkaline Phosphatase (ALP)
Time Frame: 8 weeks
Change from baseline
8 weeks
Gamma-glutamyl Transpeptidase (GGT)
Time Frame: 8 weeks
Change from baseline
8 weeks
White Blood Cells (WBCs)
Time Frame: 8 weeks
Change from baseline
8 weeks
Red Blood Cells (RBCs)
Time Frame: 8 weeks
Change from baseline
8 weeks
Hemoglobin (Hb)
Time Frame: 8 weeks
Change from baseline
8 weeks
Platelets
Time Frame: 8 weeks
Change from baseline
8 weeks
International Normalized Ratio (INR) (if Not Possible Prothrombin Time [PT = Quick-value] is Accepted)
Time Frame: 8 weeks
Change from baseline
8 weeks
Activated Partial Thromboplastin Time (aPTT)
Time Frame: 8 weeks
Change from baseline
8 weeks
Hematocrit (Hct)
Time Frame: 8 weeks
Change from baseline
8 weeks
Blood Glucose
Time Frame: 8 weeks
Change from baseline
8 weeks
Sodium
Time Frame: 8 weeks
Change from baseline
8 weeks
Chloride
Time Frame: 8 weeks
Change from baseline
8 weeks
Potassium
Time Frame: 8 weeks
Change from baseline
8 weeks
Calcium
Time Frame: 8 weeks
Change from baseline
8 weeks
Magnesium
Time Frame: 8 weeks
Change from baseline
8 weeks
Phosphate
Time Frame: 8 weeks
Change from baseline
8 weeks
Serum Creatinine
Time Frame: 8 weeks
Change from baseline
8 weeks
Triglycerides
Time Frame: 8 weeks
Change from baseline
8 weeks
Cholesterol
Time Frame: 8 weeks
Change from baseline
8 weeks
High-density Lipoprotein (HDL)
Time Frame: 8 weeks
Change from baseline
8 weeks
Low-density Lipoprotein (LDL)
Time Frame: 8 weeks
Change from baseline
8 weeks
C-reactive Protein (CRP)
Time Frame: 8 weeks
Change from baseline
8 weeks
α-Tocopherol/Vitamin E (Facultative if Routinely Assessed)
Time Frame: 8 weeks
Change from baseline
8 weeks
Triene:Tetraene Ratio in Plasma, Reduction From Baseline
Time Frame: 8 weeks
Derived from fatty acid pattern in plasma
8 weeks
Adverse Events
Time Frame: 8 weeks
Number of adverse events (including serious adverse events)
8 weeks
BMI
Time Frame: 8 weeks
Body mass index Change from baseline
8 weeks
Prothrombin Time (PT)
Time Frame: 8 weeks
Change from baseline
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
B. Braun Melsungen AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 19, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 19, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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