Yes. EleCare has been clinically studied in food-allergic children and has met current recommendations for labeling a formula as hypoallergenic. To be labeled “hypoallergenic,” the formula must be tolerated by 90% of infants and children with confirmed cow’s milk allergy, with 95% confidence when given in prospective, randomized, double-blind, placebo-controlled trials.

Yes. Scientific studies and clinical experience have shown that EleCare is well tolerated by infants and children who have multiple food allergies and other conditions. EleCare supports normal growth and tolerance in the pediatric population.

• Prior to the manufacture of EleCare, all manufacturing equipment is thoroughly cleaned using validated and documented cleaning procedures to assure that the system is free of cow’s milk and soy protein.
   
• As part of the cleaning verification, post-cleaning swab samples of equipment, product contact surfaces, and environmental areas are evaluated by ELISA (Enzyme-Linked ImmunoSorbent Assay). ELISA testing will detect the presence of minute levels of casein, whey, and soy protein. In the unlikely event that the swab results show that an area is not sufficiently clean, it is recleaned and tested until ELISA results indicate that the area is clean.
   
• Mechanical systems and trained personnel are in place to support maintenance of a “protein-free” environment, and the production line used to fill EleCare is dedicated to “protein-free” products.
   
• Following manufacture, ELISA testing is performed as part of the finished product release testing to assure that all commercial batches of EleCare meet rigorous antigen content specifications to maintain its hypoallergenic clinical performance.
   
• Each commercial batch is also tested using the ELISA and PAGE (PolyAcrylamide Gel Electrophoresis) method. The PAGE method is not as sensitive as the ELISA, but has the advantage of detecting the presence of any protein, regardless of source.

MCTs are an easily digested and well-absorbed fat source. MCTs comprise one-third of the fat in EleCare. EleCare is the only free amino acid-based infant formula providing one-third of the fat blend from MCTs.

EleCare:  

• Contains 100% free amino acids as the protein source
   
• Comprises one-third of fat as medium-chain triglycerides, an easily digested and well-absorbed fat source to benefit patients with malabsorption
   
• Is fructose-, galactose-, lactose-, and gluten-free

Yes. Abbott has performed studies in infants, and the US Food and Drug Administration (FDA) considers EleCare an appropriate feeding for infants.

EleCare is well tolerated and is the only amino acid-based medical food clinically shown to support growth of exclusively fed infants from birth to 4 months.¹

¹ Borschel MW, Ziegler EE, Wedig RT, et al. Growth of healthy term infants fed a free amino acid-based medical food. J Pediatr Gastroenterol Nutr. 2001;33:393A.

EleCare is specifically formulated for infants and children who require an amino acid-based medical food or who cannot tolerate intact protein due to severe food allergies and eosinophilic gastrointestinal disorder. It is also helpful in patients with conditions such as short bowel syndrome, chronic diarrhea, malabsorption, gastrointestinal tract impairment, and protein-sensitive colitis.

EleCare Vanilla is recommended for children age 1 year and older. It provides the same high-quality nutrition as unflavored EleCare, but with improved taste and aroma. Nine out of 10 children preferred EleCare Vanilla to unflavored EleCare,¹ which could help with compliance in your older patients. Mixing instructions, osmolality, and price are the same as unflavored EleCare.

¹ EleCare Vanilla In-House Taste Test. Data on file. Abbott Nutrition, Abbott Laboratories, December 2007.

No. It is not available over the counter.

Yes. EleCare is lactose- and galactose-free. It is also fructose-free.

Abbott Nutrition attempts to use PAREVE ingredients in EleCare and uses appropriate methods of CIP (clean-in-place) to sanitize and kosherize (for Dairy designation) equipment prior to manufacturing EleCare. Abbott Nutrition's manufacturing plants are kosher for Dairy. Abbott Nutrition conducts extensive testing to make sure the manufacturing equipment is milk-protein free prior to production and also tests the product using sensitive techniques for the presence of milk protein. Due to OU labeling requirements regarding use of equipment that manufactures both pareve and dairy products, to put an OU designation on the label, the label would need to indicate “OU Dairy” or “Pareve OU, Contains only Pareve ingredients. Manufactured on dairy equipment.” Abbott Nutrition has concluded that to have the word “Dairy” on the label would lead to confusion by parents of children who are allergic to milk proteins. Thus, Abbott Nutrition has decided not to put these designations on the label of EleCare.

Abbott Nutrition suggests that consumers for whom this is an issue, contact their rabbi to get approval to consume this product.