Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study in Patients With Cystic Fibrosis Receiving Enteral Feeding

Abstract

Objectives:Pancreatic insufficiency (PI) and malabsorption of fats lead to reduced caloric intake, inability to maintain weight, and increased gastrointestinal symptoms. Thus, enteral nutrition (EN) is used in patients with cystic fibrosis (CF) and poor nutritional status. The current study evaluated safety, tolerability, and improvement of fatty acid (FA) status in red blood cell (RBC) membranes, a marker of long-term FA absorption, with an in-line digestive cartridge (RELiZORB) that hydrolyzes fat in enteral formula.Methods:Patients with CF receiving EN participated in a multicenter, 90-day open-label study during which RELiZORB was used with overnight EN. The primary endpoint was change over time in RBC uptake of docosahexaenoic acid (DHA)+ eicosapentaenoic acid (EPA). Gastrointestinal symptoms were collected to evaluate safety and tolerability. Several clinical and anthropometric parameters were also assessed throughout the study.Results:A total of 36 subjects completed the study with a mean age of 13.8 years, body mass index of 17.7 and 6.2 years mean use of overnight EN. Fat absorption significantly improved as shown by increased RBC levels of DHA+EPA, improved ω-6/ω-3 ratio, and increased plasma levels of DHA+EPA. RELiZORB use was not associated with any unanticipated adverse events.Conclusions:RELiZORB use was found to be safe, well tolerated, and resulted in increased levels of FAs in RBCs and plasma. This is the first prospective study to show EN can improve FA abnormalities in CF. Because improvement in omega-3 levels has been shown to help pulmonary and inflammatory status as well as anthropometric parameters in CF, RELiZORB may have important long-term therapeutic benefits in patients with CF.

Chronic Pancreatitis and Nutrition Therapy

“…Coordinating sufficient enzymatic supplementation with the delivery of tube feeds is challenging. A recent clinical trial in pediatric patients with cystic fibrosis described the use of a pancreatic lipase cartridge (RELiZORB, Alcresta Therapeutics, Inc.; Newton, MA) inserted into the delivery system of enteral feeding tubes, to help improve fat absorption (Figure ) . It is a single‐use cartridge containing lipase‐coated beads through which the enteral feed passes.…”

Growth and Nutrition in Cystic Fibrosis

“…Recently, an in-line lipase-containing cartridge has been shown to safely improve fat absorption in patients on continuous enteral nutrition but is not yet widely available. 85,86…”

Management of Exocrine Pancreatic Insufficiency in Children

“…This practice allows patients to receive supplemental calories in addition to their daytime oral diet. About 10%–12% of CF patients need supplemental tube feedings . Polymeric formulas are usually used, and semi‐elemental formulas are used if the patient is intolerant to polymeric formulas .…”

“…This cartridge has also been used in younger children. When formula transverses through the cartridge, triglycerides are hydrolyzed to free fatty acids and monoglycerides by the impregnated microbial lipase . With the available evidence, the use of RELiZORB appears to be safe, convenient, and effective in CF patients requiring enteral feeds .…”

“…With the available evidence, the use of RELiZORB appears to be safe, convenient, and effective in CF patients requiring enteral feeds . In a prospective study with participants’ ages ranging 5–33 years, RELiZORB use was well tolerated and resulted in fat absorption with favorable increase in plasma and red blood cell levels of long‐chain polyunsaturated fatty acids …”