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

Freedman, Steven D.*; Wyatt, Colby; Stevens, John; Patel, Dhiren§; Gallotto, Robert||; Grujic, Danica||; Brown, Perry

Journal of Pediatric Gastroenterology and Nutrition: August 1, 2018 - Volume Publish Ahead of Print - Issue - p
doi: 10.1097/MPG.0000000000002110
Original Article: Nutrition: PDF Only

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 DHA+EPA. Gastrointestinal symptoms were collected to evaluate safety and tolerability. Several clinical and anthropometric parameters were also assessed throughout the study.

Results: 36 subjects completed the study with a mean age of 13.6 years, BMI 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. Since 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.

This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0

*Department of Medicine and Division of Translational Research, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA

Maine Medical Center, Portland, ME, USA

Riley Hospital for Children, Indianapolis, IN, 46202, USA

§SSM Cardinal Glennon Children's Medical Center, Louis, MO 63104, USA

||Alcresta Therapeutics, Inc, Warren, NJ, 07059 USA

St. Luke's Health System, 190 East Bannock Street, Boise, ID, 83712, USA.

Address correspondence and reprint requests to Steven D. Freedman, MD, PhD, Beth Israel Deaconess Medical Center, 330 Brookline Ave., Dana 501, Boston, MA 02215 (e-mail: sfreedma@bidmc.harvard.edu).

Received 10 March, 2018

Accepted 22 June, 2018

Trial identification number and URL: NCT02750501 https://clinicaltrials.gov/ct2/show/NCT02750501

Source of Support: This study was funded by Alcresta Therapeutics, Inc.

ClinicalTrials.gov Identifier: NCT02750501 - https://clinicaltrials.gov/ct2/show/NCT02750501

Authors roles in the submitted manuscript:

Steven Freedman, MD, PhD: substantial contribution to the design of the study and the analysis and interpretation of the data, as well as critical review and revision of the manuscript

Colby Wyatt, MD: substantial contribution to the acquisition of the data, as well as critical review and revision of the manuscript

Perry Brown, MD: substantial contribution to the acquisition of the data, as well as critical review and revision of the manuscript

John Stevens, MD: substantial contribution to the acquisition of the data, as well as critical review and revision of the manuscript

Dhiren Patel, MD: substantial contribution to the acquisition of the data, as well as critical review and revision of the manuscript

Danica Grujic, PhD: substantial contribution to the conception and design of the study and the analysis and interpretation of the data, as well as critical review and revision of the manuscript

All authors have reviewed and approved the submitted manuscript and agree to be accountable for all aspects of the work and will participate in addressing any questions related to the accuracy and integrity of the research and results presented in the manuscript.

Conflicts of Interest: Dr. Grujic is an employee of Alcresta Therapeutics, Inc.; Dr. Freedman has received research support from Alcresta Therapeutics, Inc. For the remaining authors, none is declared.

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Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Website (www.jpgn.org).

© 2018 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,