For the dietary management of cow's milk allergy.
* LGG is a registered trademark of Chr. Hansen A/S
Last Updated: Monday, December 18, 2017
Nutramigen with Enrlora 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 soy formulas. It is designed to help meet their growing nutritional needs. Nutramigen with Enflora LGG Toddler has extensively hydrolyzed casein protein to help avoid an immune system response by reducing the allergen exposure, and the probiotic branded LGG to help support the strength of the intestinal barrier and help support digestive health.
DHA and ARA Fatty Acid Nutrients†
† Studied in infants. ‡ When hereditary fructose intolerance is a concern.
|(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: Corn syrup solids (54%), vegetable oil (palm olein, coconut, soy and high oleic sunflower oils) (20%), casein hydrolysate (milk) (14%), modified corn starch (6%) and less than 2%: Mortierella alpina oil||, Schizochytrium Sp.¶, 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
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 formulas are not sterile and should not be fed to 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. Add powder.
Cap bottle or cup and shake well.
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.
WARNING: Do not warm. Warming may limit the benefits of LGG. Microwaving formula may cause serious burns to baby.
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.
Protein contributes 11% of total calories in Nutramigen with Enflora LGG. 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. The protein efficiency ratio (PER) for Nutramigen with Enflora LGG is greater than the PER for casein16. Thus, the protein in Nutramigen with Enflora LGG is of very high quality.
Every batch of protein hydrolysate used in Nutramigen with Enflora LGG 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 result in an approximately 1 million‑fold reduction in antigenicity compared with unmodified casein.
The amounts of fat in Nutramigen with Enflora LGG is 48% of total calories. The fat blend consists of approximately:
• 44% palm olein oil • 19.5% soy oil • 19.5% coconut oil • 14.5% high oleic sunflower oil • 2.5% single-cell oil blend rich in docosahexaenoic acid (DHA) and arachidonic acid (ARA)
The amounts of total fat and saturated, monounsaturated, and polyunsaturated fatty acids in Nutramigen with Enflora LGG are patterned after levels found in mature U.S. breast milk.
The amount of carbohydrate is 41% of total calories in Nutramigen with Enflora LGG and the product is suitable for someone with lactose intolerance. The carbohydrate blend in the powder is corn syrup solids and modified corn starch. The carbohydrates in Nutramigen with Enflora LGG are readily digested and well tolerated by infants whose ability to digest other carbohydrates, such as lactose and sucrose, is impaired17. 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 hypoallergenic18.
Nutramigen with Enflora LGG has the probiotic Lactobacillus rhamnosus GG (branded LGG). LGG is provided at a concentration of 1 x 106 CFUs‡‡ LGG culture/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 allergy19-22. Infants in these studies consumed 108 to 1010 CFU of LGG per day. Nutramigen with Enflora LGG 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.
DHA and ARA
Nutramigen with Enflora LGG has DHA and ARA, two nutrients also found in breast milk that are important building blocks for a baby's brain and eyes3-10. The amount of DHA in Nutramigen with Enflora LGG is similar to that found in average worldwide breast milk23-26,§§ as well as amounts specified by expert groups27-30.
§§ 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 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 10731.
Calcium and Phosphorus
Nutramigen with Enflora LGG has 94 mg calcium/100 Calories and 52 mg phosphorus/100 Calories. The calcium:phosphorus ratio is about 1.81:1, which is in the range specified by the Infant Formula Act31.
Nutramigen with Enflora LGG has 12.2 mg iron/L. The AAP states that infants who are not breastfed should receive iron-fortified formula32.
Electrolytes–Sodium, Potassium, and Chloride
The electrolyte amounts in Nutramigen with Enflora LGG are within the ranges specified by U.S. Food and Drug Administration regulations as mandated by the Infant Formula Act31. The sodium, potassium, and chloride amounts are 47 mg/100 Calories, 110 mg/100 Calories, and 86 mg/100 Calories, respectively.
Clinical Support for Use of LGG
Several studies have examined the ability of LGG to colonize the gut of term infants33-35. 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)22,25-31, 33-39. These studies have generally reported that infants responded better to an extensively hydrolyzed formula supplemented with LGG compared to an extensively hydrolyzed formula without LGG22,36,38,39.
A variety of research models have been used to study the ability of LGG to support healthy gut barrier function40-44. The data strongly suggest that LGG 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 system36,38,39,45.
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 that had DHA and ARA with infants fed formulas without DHA and ARA, there were no clinically significant differences in tolerance and DHA and ARA had no effect on the incidence of adverse events37,38-40. 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.41-42
1. Fomon SJ, Ziegler EE. Renal solute load and potential renal solute load in infancy. J Pediatr. 1999;134:11-14.
2. Birch EE, Garfield S, Hoffman DR, et al. A randomized controlled trial of early dietary supply of long-chain polyunsaturated fatty acids and mental development in term infants. Dev Med Child Neurol. 2000;42:174-181.
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.
6. Hoffman DR, Birch EE, Birch DG, et al. Impact of early dietary intake and blood lipid composition of long-chain polyunsaturated fatty acids on later visual development. J Pediatr Gastroenterol Nutr. 2000;31:540-553.
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.
15. Brenna JT, Varamini B, Jensen RG, et al. Docosahexaenoic and arachidonic acid concentrations in human breast milk worldwide. Am J Clin Nutr 2007;85:1457-64.
16. Canani, R., R. Nocerino, et al. (2012). "Effect of Lactobacillus GG on tolerance acquisition in infants with cow's milk allergy: a randomized trial." J Allergy Clin Immunol 129(2): 580-582, 582 e581-585.
17. Canani, R., R. Nocerino, et al. (2013). "Formula Selection for Management of Children with Cow's Milk Allergy Influences the Rate of Acquisition of Tolerance: A Prospective Multicenter Study." J Pediatr 163(3): 771-777 e771.
18. 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.
19. 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.
20. Simopoulos AP, Leaf A, Salem N Jr. Workshop on the essentiality of and recommended dietary intakes for omega-6 and omega-3 fatty acids. J Am Coll Nutr. 1999;18:487-489.
21. Koletzko B, Agostoni C, Carlson SE, et al. Long-chain polyunsaturated fatty acids (LC-PUFA) and perinatal development. Acta Paediatr. 2001;90:460-464.
22. Nutrient Requirements for Infant Formulas. Code of Federal Regulations 21, C.F.R. 107.100. April 1, 2006.
23. American Academy of Pediatrics, Committee on Nutrition. Iron fortification of infant formulas. Early Hum Dev. 1999;104:119-123.
24. 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.
25. 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.
26. 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.
27. Isolauri E, Arvola T, Sutas Y, et al. Probiotics in the management of atopic eczema. Clin Exp Allergy. 2000;20:1604-1610.
28. 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.
29. Majamaa H, Isolauri E. Probiotics: a novel approach in the management of food allergy. J Allergy Clin Immunol. 1997;99:179-185.
30. 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.
31. 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.
32. Mattar AF, Drongowski RA, Coran AG, et al. Effect of probiotics on enterocyte bacterial translocation in vitro. Pediatr Surg Int. 2001;17:265-268.
33. 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.
34. Lee DJ, Drongowski RA, Coran AG, et al. Evaluation of probiotic treatment in a neonatal animal model. Pediatr Surg Int. 2000;16:237-242.
35. 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.
36. 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.
37. Data on file, Mead Johnson Nutrition, July 1990.
38. 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.
39. 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.
40. 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.
41. 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.
42. 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.