GLENVIEW, Ill.--(BUSINESS WIRE)--A new independent, multi-center study on cow’s milk allergy has been published in the May 2013 edition of the Journal of Pediatrics. The study shows significantly more infants with cow’s milk allergy who received Nutramigen LGG, an extensively hydrolyzed formula that includes Lactobacillus rhamnosus GG (LGG), built a tolerance to cow’s milk than those fed other formulas in the study. Specifically, nearly four out of five infants (78.9 percent) fed Nutramigen LGG built tolerance to cow’s milk protein at 12 months, compared with infants fed other study products, such as extensively hydrolyzed casein formula (43.6 percent) , hydrolyzed rice formula (32.6 percent), soy based formula (23.6 percent) or amino-acid based formula (18.2 percent). Historically, children with cow’s milk allergy didn’t build tolerance until three to five years of age.
“Building a tolerance to cow’s milk at an earlier age has the potential to allow for earlier normalization of children’s diets, which can result in reduced impact on their development and potentially lower medical costs,” said study author and professor of pediatrics at the University of Naples, Roberto Canani, M.D., Ph.D. “This study adds to the growing body of evidence that shows an extensively hydrolyzed formula with LGG helps manage cow’s milk allergy fast.”
Nutramigen is the only brand with extensively hydrolyzed protein and LGG. It contains a milk protein that is broken down into tiny pieces to virtually eliminate allergic reactions. While LGG is one of the most studied probiotics for allergy, this is the first study to compare the impact of Nutramigen LGG to other formulas based on symptom duration in infants with cow’s milk allergy. The study is specific to Nutramigen with LGG infant formula. The results cannot be generalized to other probiotics or other Lactobacillus strains, since they all have different modes of action and varied effectiveness in model immune cell systems.
“We are pleased to see data further proving Nutramigen LGG, a brand trusted by moms and doctors alike, helps infants more quickly build tolerance to cow’s milk,” said Carol Lynn Berseth, M.D., Director of Medical Affairs at Mead Johnson Nutrition. “Recognizing and managing cow’s milk allergy early is important to helping infants get back on track to healthy growth and development.”
Cow’s milk allergy is the most common food allergy in infants 12 months and under. It can cause digestive problems, breathing difficulties, rashes or swelling of the face. Recent studies suggest the severity and duration of cow’s milk allergy is increasing, which may limit an infant’s diet, potentially leading to growth, development and health issues. The European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) guidelines recommend the use of an extensively hydrolyzed protein in most infants with cow’s milk allergy. Nutramigen has been widely studied for more than 70 years.
About the Study
The open non-randomized 12-month trial evaluated the rate of tolerance to cow’s milk in 260 children aged one to 12 months diagnosed with cow’s milk allergy who were fed extensively hydrolyzed casein formula (n=55), extensively hydrolyzed casein formula plus Lactobacillus GG (n=71), hydrolyzed rice formula (n=46), soy formula (n=55) or amino acid based formula (n=33). Full clinical evaluations were performed at six and 12 months to evaluate whether subjects had achieved oral tolerance to cow’s milk protein.
The rate of children building oral tolerance to cow’s milk at 12 months was significantly higher (p<0.05) in the groups receiving EHCF + LGG (78.9 percent) and EHCF (43.6 percent) compared with the other groups: RHF (32.6 percent), SF (23.6 percent) and AAF (18.2 percent).* Binary logistic regression analysis revealed that the rate of patients building tolerance at the end of the study was influenced by two factors: 1) IgE-mediated mechanism and 2) formula choice. Patients who built tolerance were re-evaluated six months after trial completion to check the continued tolerance. The study was approved by the Ethics Committee of the University of Naples “Federico II.”
Study authors include:
- Roberto Berni Canani, Department of Pediatrics, European Laboratory for the Investigation of Food Induced Diseases, University of Naples “Federico II”, Naples, Italy
- Rita Nocerino, Department of Pediatrics
- Gianluca Terrin, Department of Gynecology-Obstetrics and Perinatal Medicine, University of Rome “La Sapienza”, Rome, Italy
- Tullio Frediani, Department of Pediatrics, University of Rome “La Sapienza”, Rome, Italy
- Sandra Lucarelli, Department of Pediatrics, University of Rome “La Sapienza”, Rome, Italy
- Linda Cosenza, Department of Pediatrics, University of Naples “Federico II”, Naples, Italy
- Annalisa Passariello, Neonatology and Pediatric Unit, Monaldi Hospital, Naples, Italy
- Ludovica Leone, Department of Pediatrics, University of Naples “Federico II”, Naples, Italy
- Viviana Granata, Department of Pediatrics, University of Naples “Federico II”, Naples, Italy
- Margherita Di Costanzo, Department of Pediatrics, University of Naples “Federico II”, Naples, Italy
- Vincenza Pezzella, Department of Pediatrics, University of Naples “Federico II”, Naples, Italy
- Riccardo Troncone, Department of Pediatrics, European Laboratory for the Investigation of Food Induced Diseases, University of Naples “Federico II”, Naples, Italy
* Infant formula products used in the study included EHCF+LGG (Nutramigen LGG), EHCF (Nutramigen, Nutriben), RHF (Risolac), SF (Isomil, Sinilac and Nutrilon Soya), AAF (Neocate, Nutramigen AA and Sineall).
About Mead Johnson (NYSE: MJN)
Mead Johnson, a global leader in pediatric nutrition, develops, manufactures, markets and distributes more than 70 products in over 50 markets worldwide. The company's mission is to nourish the world's children for the best start in life. The Mead Johnson name has been associated with science-based pediatric nutrition products for over 100 years. The company's "Enfa" family of brands, including Enfamil® infant formula, is the world's leading brand franchise in pediatric nutrition.
For more information on the company, go to www.meadjohnson.com.
