Entrinsic Health Solutions and Brigham and Women’s Hospital Launch Pilot Study in Patients with Inflammatory Bowel Disease
— Study to Analyze Effects of enterade® Versus Sports Drink on Gastrointestinal Function, Inflammation, and Fluid Balance —
NORWOOD, Mass., April 30, 2018 – Entrinsic Health Solutions in partnership with Brigham and Women’s Hospital today announced the initiation of its pilot study evaluating enterade® – a sugar-free, amino acid based hydration solution – versus the current standard of care, a glucose-based sports drink, in patients with inflammatory bowel disease (IBD) who have had sections of their colons removed. Findings from this study could have broad implications for patients with malabsorption, dehydration, and general gastrointestinal (GI) dysfunction resulting from many underlying conditions, including IBD.
The objectives of this multi-center study are to: 1) test the efficacy of enterade compared to the current standard of care, a popular sports drink, to improve hydration in patients; 2) assess general well-being of patients with IBD status post-colectomy to determine the tolerability, feasibility, and safety of long-term use of enterade; and 3) explore the potential anti-inflammatory effects of enterade in patients with IBD.
“Patients with IBD who have undergone a colectomy often have difficulty maintaining an adequate fluid balance and rely on their small intestine to absorb water, which significantly limits absorption,” said Joshua Korzenik, MD, Principal Investigator at Brigham and Women’s Hospital. “Therefore, colectomy patients often receive oral rehydration solutions, like sports drinks, or IV hydration to supplement their fluid intake. Our hypothesis is that substituting enterade as an oral rehydration solution may help these patients better maintain fluid balance.”
“In the U.S., 1.6 million people suffer from inflammatory bowel disease, which includes Crohn’s disease and ulcerative colitis. Many of these patients struggle to maintain hydration. Recent studies have shown that glucose-based solutions may actually increase fluid loss and limit rates of absorption. We are hopeful that this study will demonstrate a new and effective option for increased fluid absorption, decreased GI output, and improved hydration status increasing overall well-being and energy,” said Stephen Gatto, Chief Executive Officer at Entrinsic Health Solutions. “enterade’s glucose-free formulation and specific blend of amino acids offers an alternative to the current standard of care and is expected to restore normal bowel function.”
Eighteen eligible patients will be randomized to a treatment arm: enterade or sports drink. Each patient will go through a two-week screening period to establish a baseline and determine final eligibility for the trial. After the screening, patients will continue on into the intervention portion of the trial, when they will start drinking either enterade or a sports drink. Treatments will be single blinded, and patients will consume 8 oz. of their assigned hydration solution, twice daily for the first four weeks of the randomized blinded intervention. After the initial four weeks, enterade will be given to both groups in the same dose during an optional four week open label intervention period. Researchers will analyze any changes in GI output to assess if enterade affects chloride secretion, as measured by change in diarrhea. Overall well-being will also be assessed using questionnaires, wrist-worn activity trackers, Bluetooth enabled scales, Bluetooth enabled water bottle trackers, and wireless blood pressure monitors.
Patients will be recruited from the Crohn’s and Colitis Center at Brigham and Women’s Hospital, Gastroenterology Associates of Rhode Island, Dartmouth-Hitchcock Medical Center and from other physicians who refer their patients to the study site. For more information on the study, please visit ClinicalTrials.gov (ID: NCT03451253) or contact Dr. Joshua Korzenik at IBDresearch@bwh.harvard.edu.
enterade is a first-in-class, glucose-free medical food that is composed of five critical amino acids (Valine, Aspartic Acid, Serine, Threonine, Tyrosine) and electrolytes (potassium and sodium) to help manage debilitating gastrointestinal (GI) side effects. With no sugar to exacerbate the GI tract, enterade supports the small bowel’s ability to absorb fluids, nutrients, and electrolytes and leads to improved digestive function. By helping to restore normal GI function, enterade reduces diarrhea and dehydration, leading to a significant improvement in the patient’s overall quality of life and a healthier GI tract. For more information, please visit us at www.enterade.com and connect with the brand on Facebook, Instagram, and Twitter.
About the Crohn’s and Colitis Center at Brigham and Women’s Hospital
The Crohn’s and Colitis Center at Brigham and Women’s Hospital is a tertiary referral center for patients with Inflammatory Bowel Disease (IBD). The physicians at our center recognize that when people are ill, it affects their whole person. The path to wellness requires support and understanding of each and every patient’s individual needs and we offer unique and innovative models of care for our patients. Our team consists of some of the most accomplished IBD specialists, researchers, and educators in the world. We continue to lead the way in pioneering IBD research and are at the forefront of many of the latest clinical advancements.
About Entrinsic Health Solutions
Entrinsic Health Solutions, Inc., is an innovative health sciences company dedicated to the development and commercialization of amino acid-based medical technologies to address critical digestive health, nutrition and hydration related health issues. The Company’s proprietary Amino Acid Coupled Transport (A₂CT) Technology platform leverages gold-standard science and game-changing amino acid technology to address critical digestive and hydration-related health issues. A2CT technology uses select amino acids to facilitate active transport of electrolytes throughout the body, which delivers rapid hydration, decreased gut permeability and improved nutrient absorption, supporting long-term digestive health. For more information, please visit us at www.entrinsichealth.com.