New Journal of Pediatrics Study Shows Strong Benefits Provided by Nutramigen® LGG® Infant Formula in the Management of Cow’s

  New Journal of Pediatrics Study Shows Strong Benefits Provided by
  Nutramigen® LGG® Infant Formula in the Management of Cow’s Milk Allergy

   Significantly More Infants Build Tolerance to Cow’s Milk at 12 Months on
            Nutramigen LGG Compared to Other Products in the Study

Business Wire

GLENVIEW, Ill. -- April 22, 2013

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.

Contact:

Mead Johnson Nutrition Company Media Contact:
Chris Perille, 847-832-2178
chris.perille@mjn.com
 
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