The HOME Study
Research type
Research Study
Full title
A RANDOMIZED, CONTROLLED, DOUBLE-BLIND, MULTICENTER CLINICAL TRIAL ON HOME PARENTERAL NUTRITION USING AN OMEGA-3 FATTY ACID ENRICHED MCT/LCT LIPID EMULSION
IRAS ID
233097
Contact name
Nicole Lincke
Contact email
Sponsor organisation
B. Braun Melsungen AG
Eudract number
2015-000849-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
Research Summary
Patients suffering from chronic intestinal failure who receive nutrition on a long term through their vein are being invited to take part in this clinical trial which investigates the use of lipid emulsions in home parenteral nutrition (HPN).The lipid emulsion to be investigated contains omega-3 fatty acid triglycerides, which are derived from fish oil (e. g. salmon or tuna). The trade name of this product is Lipidem®. It will be compared against a lipid emulsion which does not contain fish oil (Lipofundin® MCT). Both products are marketed and used in routine.
The trial is conducted in up to 15 hospitals in up to 7 countries to extend the knowledge on the safety and tolerability of Lipidem® when administered to patients on HPN. Special attention is given to the influence on liver function parameters. It is planned to enrol 160 patients in total.
Patients will keep the parenteral nutrition scheme they had before trial start – only the lipid component will be exchanged for the investigational product. Patients will be randomly allocated to receive either Lipidem® or Lipofundin® MCT. The trial is double-blind, which means that neither patients nor investigators will know the allocated product.
Each patient will be treated in the trial for about 8 to 12 weeks and will come to the hospital for 3 visits in total. Next to the routine assessments some extra blood will be taken and the patients get a questionnaire on quality of life which they are asked to complete on site. A patient diary to capture administration of HPN will be provided and should be completed at home on a daily base.
Lay summary of study results
The HOME Study The study compared two products that are both suitable to be used as part of the intravenous nutrition for patients with chronic intestinal failure. Chronic intestinal failure is a rare disease. It can persist for many years or life-long. These patients are not able to cover their nutritional needs via oral food and receive their nutrition to a high extend by means of infusion, which is mostly realised by home parenteral nutrition.
The two products under investigation were Lipidem, a lipid emulsion that contains omega-3 fatty acids, and Lipofundin MCT without omega-3. Both products are marketed in many countries worldwide. The aim of the study was to prove that Lipidem is as safe and tolerated as Lipofundin MCT when used for 8 weeks. Seventy-four patients could be enrolled, which was approximately half of the planned patient number. Therefor it was not possible to formally show the primary aim of the study, which was the statistical proof of non-inferiority of Lipidem to Lipofundin with regards to liver function. However, from clinical perspective both treatments were well tolerated and safe, and comparable regarding liver function when used for home parenteral nutrition for 8 weeks on average up to 12 weeks. Also, other laboratory and medical parameters were comparable. In addition, Lipidem supported a better supply with essential fatty acids, which can help to prevent a deficiency in the long-term treatment.
REC name
London - Chelsea Research Ethics Committee
REC reference
18/LO/0569
Date of REC Opinion
4 Jun 2018
REC opinion
Further Information Favourable Opinion