For cow's milk allergy.
* LGG is a registered trademark of Valio LTD.
Last Updated: Monday, October 5, 2015
Indication: Nutramigen with Enflora LGG Toddler is an iron-fortified, hypoallergenic infant formula for older infants and toddlers who are allergic to the intact proteins in cow’s milk or allergic to soy formulas. It is designed to help meet their growing nutritional needs. Nutramigen with Enflora LGG Toddler contains extensively hydrolyzed protein to help avoid an immune system response by reducing the allergen exposure, and the probiotic LGG to help support the strength of the intestinal barrier and help support digestive health.
DHA and ARA Fatty Acid Nutrients†
† Per 100 Calories.
|(Normal Dilution)||Per 100 Calories (5 fl oz)||Per 100 grams Powder (480 Cal)|
|Linoleic acid, mg||640||3100|
|(Normal Dilution)||Per 100 Calories (5 fl oz)||Per 100 grams Powder (480 Cal)|
|Vitamin A, IU||300||1440|
|Vitamin D, IU||60||290|
|Vitamin E, IU||1.65||7.9|
|Vitamin K, mcg||13||62|
|Thiamin (Vitamin B1), mcg||110||530|
|Riboflavin (Vitamin B2), mcg||180||860|
|Vitamin B6, mcg||154||740|
|Vitamin B12, mcg||0.3||1.44|
|Folic acid (Folacin), mcg||16||77|
|Pantothenic acid, mcg||660||3200|
|Vitamin C (Ascorbic acid) mg||19||91|
|(Normal Dilution)||Per 100 Calories (5 fl oz)||Per 100 grams Powder (480 Cal)|
§ Product nutrient values and ingredients are subject to change. Please see product label for current information.
|Nutrient Density||20 calories/fl oz|
|Protein (% Calories)||10|
|Fat (% Calories)||39|
|Carbohydrate (% Calories)||51|
|Potential Renal Solute Load (mOsm/100 Calories)1||24|
|Potential Renal Solute Load (mOsm/100 mL)1||15.9|
|Osmolality (mOsm/kg water)||300|
|Lactose-Free||Suitable for someone with lactose intolerance|
Nutramigen® with Enflora™ LGG® Toddler is available in powder.
Item #: 154801
Unit Size: 12.6 oz can (357 g)
Prod. Yield / Unit (fl oz): 86
Case: 6 cans per case
Reimbursement Code: 00087-510734
Ingredients: Powder: Corn syrup solids (45%), vegetable oil (palm olein, soy, coconut and high oleic sunflower oils) (20%), casein hydrolysate§ (from milk) (14%), fructose (10%) modified corn starch (6%) and less than 2%: Mortierella alpina oil||, Crypthecodinium cohnii oil¶, Lactobacillus rhamnosus GG (LGG), vitamin A palmitate, vitamin D3, vitamin E acetate, vitamin K1, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, vitamin B12, niacinamide, folic acid, calcium pantothenate, biotin, ascorbic acid, choline chloride, inositol, calcium citrate, calcium hydroxide, calcium phosphate, magnesium oxide, ferrous sulfate, zinc sulfate, manganese sulfate, cupric sulfate, sodium iodide, sodium selenite, sodium citrate, potassium citrate, potassium chloride, L-cystine, L-tyrosine, L-tryptophan, taurine, L-carnitine.
§ Modified to be better tolerated in milk-allergic babies. || A source of arachidonic acid (ARA). ¶ A source of docosahexaenoic acid (DHA).
Nutramigen with Enflora LGG Toddler contains milk and soy. Nutramigen with Enflora LGG Toddler is hypoallergenic. Allergic reactions to extensively hydrolyzed casein formulas are not commonly reported.
The baby’s health depends on carefully following these instructions. Proper hygiene, preparation, dilution, use and storage are important when preparing infant formula. Powdered infant formulas are not sterile and should not be fed to premature infants or infants who might have immune problems, unless directed and supervised by a doctor.
Discuss with parents whether they need to use cooled, boiled water for mixing and whether they need to boil clean utensils, bottles and nipples in water before use.
Wash hands thoroughly with soap and water before preparing formula.
Pour the desired amount of water into the bottle or cup. The amount necessary depends on the desired amount of formula. See following chart.
Mix powder formula with cool water (35°-75°F); it should feel cool on your wrist. Do not warm. Warming can limit benefits of LGG. Microwaving formula can cause serious burns to baby.
NOTE: Never use hot tap water.
Use the following chart for correct amounts of water and powder. Use scoop in can to measure powder. Store DRY scoop in its original can.
|6 fl oz bottle||6 fl oz||3 packed level scoops||27.9 g|
|8 fl oz bottle||8 fl oz||4 packed level scoops||37.2 g|
# Each scoop adds about 0.2 fl oz to the amount of prepared formula.
Failure to follow these instructions could result in severe harm. Once prepared, formula can spoil quickly. Either immediately feed or immediately cover and refrigerate at 35°—40°F (2°—4°C) for no longer than 24 hours. Do not use prepared formula if it is unrefrigerated for more than a total of 2 hours. Do not freeze prepared formula. After feeding begins, use within 1 hour or discard.
Powder Storage Cans
Store cans at room temperature. After opening can, keep tightly covered, store in dry area, and use contents within 1 month. Do not freeze powder, and avoid excessive heat. Use by date on bottom of can.
CAUTION This product is not recommended for routine use in very low-birth-weight infants. Some of these infants may be at increased risk of developing gastrointestinal complications.
WARNING: Do not warm. Warming may limit the benefits of LGG. Microwaving formula may cause serious burns to baby.
Protein provides 10% of total calories in Nutramigen with Enflora LGG Toddler. The hypoallergenic protein source is extensively hydrolyzed casein that is supplemented with three amino acids—L-cystine, L-tyrosine, and L-tryptophan—to provide an appropriate balance of amino acids to the infant. The protein source provides a high percentage of free amino acids with the remainder as small peptides. Thus, the protein in Nutramigen with Enflora LGG Toddler is of very high quality.
Every batch of protein hydrolysate used in Nutramigen with Enflora LGG Toddler is tested for antigenicity using a procedure that detects the ability of a peptide to bind to a casein specific antibody. The hydrolysates used in Nutramigen with Enflora LGG Toddler result in an approximately 1 million fold reduction in antigenicity compared with unmodified casein.
The fat content in Nutramigen with Enflora LGG Toddler is 39% of total calories. The fat blend consists of approximately:
The levels of total fat and saturated, monounsaturated, and polyunsaturated fatty acids in Nutramigen with Enflora LGG Toddler are patterned after levels found in mature U.S. breast milk.
Carbohydrate provides 51% of total calories in Nutramigen with Enflora LGG Toddler and the product is suitable for someone with lactose intolerance. The carbohydrate blend is corn syrup solids, fructose and modified corn starch. The carbohydrates in Nutramigen with Enflora LGG Toddler are readily digested and well tolerated by infants whose ability to digest lactose is impaired9. The production of corn syrup solids and modified corn starch includes filtration and purification procedures that remove protein, the allergenic component of corn; therefore, these carbohydrate sources are considered hypoallergenic10.
Nutramigen with Enflora LGG Toddler contains the probiotic Lactobacillus rhamnosus GG (LGG). LGG is provided at a concentration of 1 x 106 CFUs** LGG/g of powder formula. The appropriate minimum daily amount of probiotic required to achieve a health benefit depends on the specific probiotic strain and the specific desired benefit. Clinical trials have shown that LGG is effective in managing infants with allergy11-14. Infants in these studies consumed 108 to 1010 CFU of LGG per day. Nutramigen with Enflora LGG Toddler provides approximately 108 to 1010 CFUs of LGG per day, based on proper dilution and an average daily intake of 800 mL of formula.
** CFU=Colony forming unit.
Nutramigen with Enflora LGG Toddler has DHA, a nutrient also found in breast milk that is an important building block for a baby's brain and eyes1-8. The level of DHA in Nutramigen with Enflora LGG Toddler is similar to that found in average worldwide breast milk15-18,†† as well as levels specified by expert groups19-22.
†† Average level of DHA in worldwide breast milk is 0.32% ± 0.22% (mean ± standard deviation of total fatty acids) based on an analysis of 65 studies of 2,474 women.
Vitamins and Minerals
Nutramigen with Enflora LGG Toddler meets U.S. Food and Drug Administration requirements for vitamins and minerals as mandated by the U.S. Infant Formula Act and the associated Code of Federal Regulations 21 C.F.R. part 10723.
Calcium and Phosphorus
Nutramigen with Enflora LGG Toddler contains 130 mg calcium/100 Calories and 72 mg phosphorus/100 Calories. The calcium:phosphorus ratio is about 1.81:1, which is in the range specified by the Infant Formula Act23.
Nutramigen with Enflora LGG Toddler provides 10.8 mg iron/L. The AAP states that infants who are not breastfed should receive iron-fortified formula24.
Electrolytes-Sodium, Potassium, and Chloride
The electrolyte levels in Nutramigen with Enflora LGG Toddler are within the ranges specified by U.S. Food and Drug Administration regulations as mandated by the Infant Formula Act27. The sodium, potassium, and chloride levels are 37 mg/100 Calories, 122 mg/100 Calories, and 80 mg/100 Calories, respectively.
Clinical Support for Use of LGG
Several studies have examined the ability of LGG to colonize the gut of term infants25-27. These studies show that LGG is capable of surviving intestinal transit in infants. In term infants, the oral administration of LGG for up to six months resulted in good rates of LGG colonization.
To date, a number of studies have assessed the efficacy of LGG in the dietary management of infants with cow milk protein allergy (CMPA)14, 25-31. These studies have generally reported that infants responded better to an extensively hydrolyzed formula supplemented with LGG compared to the same extensively hydrolyzed formula without this supplement14,28,30,31.
A variety of research models have been used to study the ability of LGG to support healthy gut barrier function32-35. The data strongly suggest that LGG supplementation helps support the integrity of the gut barrier.
Additionally, clinical studies of infants with CMPA indicate that LGG helps support healthy, balanced immune functions based on observations of biomarkers of the immune system28,30,31,37. Additionally, a clinical study demonstrated that healthy term infants tolerated an extensively hydrolyzed casein formula with Enflora LGG especially well38.
In summary, there is compelling clinical evidence that LGG improves the dietary management of infants with CMPA beyond the use of an extensively hydrolyzed formula alone. For infants with CMPA, the benefits of having LGG in an extensively hydrolyzed formula may be due to the ability of LGG to assist in supporting healthy gut barrier and balanced immune functions.
Clinical Support for Use of DHA and ARA
The sources of DHA and ARA in Nutramigen are well tolerated. In clinical studies comparing infants fed formulas including DHA and ARA with infants fed formulas without DHA and ARA, there were no clinically significant differences in tolerance and the addition of DHA and ARA had no effect on the incidence of adverse events38-44. The sources of DHA and ARA in Nutramigen are Generally Recognized as Safe (GRAS) for use in infant formulas by the U.S. Food and Drug Administration.45,46
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3. Birch EE, Hoffman DR, Castañeda YS, et al. A randomized controlled trial of long-chain polyunsaturated fatty acid supplementation of formula in term infants after weaning at 6 wk of age. Am J Clin Nutr. 2002;75:570-580.
4. Hoffman DR, Birch EE, Castañeda YS, et al. Visual function in breast-fed term infants weaned to formula with or without long-chain polyunsaturates at 4 to 6 months: a randomized clinical trial. J Pediatr. 2003;142:669-677.
5. Hoffman DR, Birch EE, Castañeda YS, et al. Maturation of visual and mental function in 18-month old infants receiving dietary long-chain polyunsaturated fatty acids (LCPUFAs) [abstract]. FASEB J. 2003;17:A727-A728. Abstract 445.1.
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7. Birch EE, Castañeda YS, Wheaton DH, et al. Visual maturation of term infants fed long-chain polyunsaturated fatty acid-supplemented or control formula for 12 mo. Am J Clin Nutr. 2005;81:871-879.
8. Morale SE, Hoffman DR, Castañeda YS, et al. Duration of long-chain polyunsaturated fatty acids availability in the diet and visual acuity. Early Hum Dev. 2005;81:197-203.
9. Ziegler EE, Fomon SJ. Methods in infant nutrition research: balance and growth studies. Acta Paediatr Scand Suppl. 1982;299:90-96.
10. Richardson GG, Leary HL, Halsey JF. Allergenicity of corn-derived carbohydrate ingredients for use in infant formulas [abstract]. Presentation at American College of Allergists 5th International Food Allergy Symposium. October 15-18,1984.
11. Isolauri E, Arvola T, Sütas Y, et al. Probiotics in the management of atopic eczema. Clin Exp Allergy. 2000;30:1604-1610.
12. Majamaa H, Isolauri E. Probiotics: a novel approach in the management of food allergy. J Allergy Clin Immunol. 1997;99:179-185.
13. Baldassarre M, Laforgia N, Grosso R, et al. Lactobacillus GG improves recovery from cow milk allergy colitis compared to extensively hydrolyzed formula alone. Presented at: Europaediatrics 2008; June 14-17, 2008; Istanbul, Turkey. Presentation PP-877.
14. Kirjavainen PV, Salminen SJ, Isolauri E. Probiotic bacteria in the management of atopic disease: underscoring the importance of viability. J Pediatr Gastroenterol Nutr. 2003;36:223-227.
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17. Data on file, Mead Johnson Nutrition, September 2002.
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19. The British Nutrition Foundation. Recommendations for intakes of unsaturated fatty acids. In: Unsaturated Fatty Acids: Nutritional and physiological significance: The Report of the British Nutrition Foundation's Task Force. London: Chapman & Hall; 1992:152-163.
20. FAO/WHO Joint Expert Consultation. Lipids in early development. In: Fats and oils in human nutrition. Report of a joint expert consultation. Food and Agriculture Organization of the United Nations and the World Health Organization. FAO Food and Nutr Pap. 1994;57:49-55.
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22.Koletzko B, Agostoni C, Carlson SE, et al. Long-chain polyunsaturated fatty acids (LC-PUFA) and perinatal development. Acta Paediatr. 2001;90:460-464.
23. Nutrient Requirements for Infant Formulas. Code of Federal Regulations 21, C.F.R. 107.100. April 1, 2006.
24. American Academy of Pediatrics, Committee on Nutrition. Iron fortification of infant formulas. Early Hum Dev. 1999;104:119-123.
25. Sepp E, Mikelsaar M, Salminen S. Effect of administration of Lactobacillus casei strain GG on the gastrointestinal microbiota of newborns. Microb Ecol Health Dis. 1993;6:309-314.
26. Petschow BW, Figueroa R, Harris CL, et al. Effects of feeding an infant formula containing Lactobacillus GG on the colonization of the intestine: a dose-response study in healthy infants. J Clin Gastroenterol. 2005;39:786-790.
27. Vendt N Grünberg H, Tuure T, et al. Growth during the first 6 months of life in infants using formula enriched with Lactobacillus rhamnosus GG: Double bilind, randomized trial. J Hum Nutr Diet. 2006;19:51-58.
28. Isolauri E, Arvola T, Sutas Y, et al. Probiotics in the management of atopic eczema. Clin Exp Allergy. 2000;20:1604-1610.
29. Brouwer ML, Wolt-Plompen SAA, Dubois AEJ, et al. No effects of probiotics on atopic dermatitis in infancy: a randomized placebo-controlled trial. Clin Exp Allergy. 2006;36:899-906.
30. Majamaa H, Isolauri E. Probiotics: a novel approach in the management of food allergy. J Allergy Clin Immunol. 1997;99:179-185.
31. Baldassarre M, Laforgia N, Grosso R, et al. Lactobacillus GG improves recovery from cow milk allergy colitis compared to extensively hydrolyzed formula alone. Dig Liv Dis. 2008;40:A82.
32. Isolauri E, Majamma H, Arvola T, et al. Lactobacillus casei strain GG reverses increases intestinal permeability induced by cow milk in suckling rats. Gastroenterology. 1993;105:1643-1650.
33. Mattar AF, Drongowski RA, Coran AG, et al. Effect of probiotics on enterocyte bacterial translocation in vitro. Pediatr Surg Int. 2001;17:265-268.
34. Isolauri E, Kaila M, Arvola T, et al. Diet during rotavirus enteritis affects jejunal permeability to macromolecules in suckling rats. Pediatr Res. 1993;33:548-553.
35. Lee DJ, Drongowski RA, Coran AG, et al. Evaluation of probiotic treatment in a neonatal animal model. Pediatr Surg Int. 2000;16:237-242.
36. Gotteland M, Cruchet S, Verbeke S. Effect of Lactobacillus ingestion on the gastrointestinal mucosal barrier alterations induced by indometacin in humans. Aliment Pharmacol Ther. 2001;15:11-17.
37. Pessi T, Sütas Y, Hurme M, et al. Interleukin-10 generation in atopic children following oral Lactobacillus rhamnosus GG. Clin Exp Allergy. 2000;30:1804-1808.
38. Data on file, Mead Johnson Nutrition, July 1990.
39. Cordano A, Gastanaduy AS, Graham GG. Absorption and retention from an iso-osmolal casein hydrolysate infant formula. Nutrition Research. 1988;8:1353-1362.
40. Data on file, Mead Johnson Nutrition.
41. Mennella JA, Beauchamp GK. Developmental changes in the acceptance of protein hydrolysate formula. J Dev Behav Pediatr. 1996;17:386-391.
42. Clandinin MT. Van Aerde JE, Merkel KL, et al. Growth and development of preterm infants fed infant formulas containing docosahexaenoic acid and arachidonic acid. J Pediatr. 2005;146:461-468.
43. Carlson SE, Mehra S, Kagey WJ, et al. Growth and development of term infants fed formulas with docosahexaenoic acid (DHA) from algal oil or fish oil and arachidonic acid (ARA) from fungal oil [abstract]. Pediatr Res. 1999;45:278A. Abstract 1639.
44. Wheaton DH, Castañeda YS, Hoffman DR, et al. Biosafety of docosahex-aenoic acid (DHA)/arachidonic acid (ARA) enriched infant formula fed for 9 months [abstract]. J Am Coll Nutr. 2003;22:469. Abstract 56.
45. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition website. Agency response letter GRAS Notice No. GRN 000041. Available at: http://www.cfsan.fda.gov/~rdb/opa-g041.html. Accessed April 19, 2007.
46. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition website. Agency response letter GRAS Notice No. GRN 000080. Available at: http://www.cfsan.fda.gov/~rdb/opa-g080.html. Accessed April 19, 2007.