For the dietary management of cow's milk allergy.
* LGG is a registered trademark of Chr. Hansen. A/S.
Last Updated: Thursday, December 14, 2017
Berni Canani R, et al. J Allergy Clin. Immunol. 2012;129:580-582. Journal of Pediatrics. March 2010;397-401.
Nutramigen with Enflora LGG is a 20 Cal/fl oz, iron-fortified, lactose-free, hypoallergenic infant formula designed for infants who are allergic to the intact proteins in cow’s milk and soy formulas. Nutramigen with Enflora LGG 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 support digestive health.
In cases of continued food allergies or intolerances, Nutramigen with Enflora LGG is sometimes used as a milk substitute in the diet of children beyond 12 months of age. When Nutramigen is used as a milk substitute beyond 12 months of age, the total calcium content of the diet should be assessed.
Extended use of Nutramigen with Enflora LGG (or other infant formulas) as a sole source of diet is most appropriately monitored by physicians and nutritionists on a case-by-case basis.
† Some studies were prior to the addition of DHA, ARA and LGG. ‡ When managing colic due to cow's milk allergy. Studied before the addition of DHA, ARA and LGG.
Product nutrient values and ingredients are subject to change. Please see product label for current information.
|(Normal Dilution)||Per 100 Calories (5 fl oz)||Per 100 mL||Per 100 grams Powder (510 Cal)|
|Linoleic acid, mg||860||580||4300|
|(Normal Dilution)||Per 100 Calories (5 fl oz)||Per 100 mL||Per 100 grams Powder (510 Cal)|
|Vitamin A, IU||300||200||1520|
|Vitamin D, IU||50||34||250|
|Vitamin E, IU||2||1.35||10.1|
|Vitamin K, mcg||9||6.1||45|
|Thiamin (Vitamin B1), mcg||80||54||400|
|Riboflavin (Vitamin B2), mcg||90||61||450|
|Vitamin B6, mcg||60||41||300|
|Vitamin B12, mcg||0.3||0.2||1.52|
|Folic acid (Folacin), mcg||16||10.8||81|
|Pantothenic acid, mcg||500||340||2500|
|Vitamin C (Ascorbic acid), mg||12||8.1||61|
|(Normal Dilution)||Per 100 Calories (5 fl oz)||Per 100 mL||Per 100 grams Powder (510 Cal)|
|Nutrient Density||20 Calories/fl oz|
|Protein (% Calories)||11|
|Fat (% Calories)||48|
|Carbohydrate (% Calories)||41|
|Potential Renal Solute Load (mOsm/100 Calories)14||25|
|Potential Renal Solute Load (mOsm/100 mL)14||16.9|
|Osmolality (mOsm/kg water)||300|
Nutramigen® with Enflora™ LGG® is available in powder.
Item #: 123901
Unit Size: 12.6 oz can (357 g)
Prod. Yield / Unit (fl oz): 87
Case: 6 cans per case
Reimbursement Code: 00087-123941
Item #: 123905
Unit Size: 19.8 oz can (561 g)
Prod. Yield / Unit (fl oz): 139
Case: 4 cans per case
Reimbursement Code: 00087-123945
Ingredients: Corn syrup solids (48%), vegetable oil (palm olein, coconut, soy and high oleic sunflower oils) (26%), casein hydrolysate (milk) (16%)#, modified corn starch (4%) and less than 2%: Mortierella alpina oil**, Crypthecodinium cohnii oil††, Lactobacillus rhamnosus GG‡‡, calcium citrate, calcium phosphate, potassium chloride, potassium citrate, sodium citrate, calcium hydroxide, magnesium oxide, ferrous sulfate, zinc sulfate, cupric sulfate, manganese sulfate, sodium iodide, sodium selenite, choline chloride, ascorbic acid, niacinamide, calcium pantothenate, vitamin D3, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, folic acid, vitamin K1, biotin, vitamin B12, inositol, vitamin A palmitate, vitamin E acetate, 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). ‡‡ Branded as LGG, a registered trademark of Chr. Hansen A/S.
Nutramigen with Enflora LGG contains milk and soy. Nutramigen with Enflora LGG is hypoallergenic. Allergic reactions to extensively hydrolyzed casein formulas are not commonly reported.
The baby s health depends on carefully following these instructions. Prope 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 are immunocompromised, 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.
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.
|2 fl oz bottle||2 fl oz||1 packed level scoop||9g|
|4 fl oz bottle||4 fl oz||2 packed level scoop||18 g|
|6 fl oz bottle||6 fl oz||3 packed level scoop||27 g|
|8 fl oz bottle||8 fl oz||4 packed level scoop||36 g|
|1 quart||28.5 fl oz||1 1/4 packed level household measuring cups||128 g|
†† Each scoop ad s about 0.2 fl oz to the amount of prepared formula.
WARNING: Do not warm, wanning may limit benefits of LGG culture, microwaving formula may cause serious burns to baby.
Failure to follow these instructions could result in severe harm. Once prepared, infant formula can spoil quickly. Either feed or immediately cover and store in refrigerator at 35o-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 it tightly covered, store in a dry area and use contents within 1 month. Do not freeze powder, and avoid excessive heat. Use by date on the bottom of can.
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 allergy11-12,19-22. 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,§§ as well as amounts specified by expert groups24-27.
§§ 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 10728.
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 Act28.
Nutramigen with Enflora LGG has 12.2 mg iron/L. The AAP states that infants who are not breastfed should receive iron-fortified formula29.
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 Act28. 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 infants30-32. 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)11-12,22,33-36. These studies have generally reported that infants responded better to an extensively hydrolyzed formula supplemented with LGG compared to an extensively hydrolyzed formula without LGG11-12,22,33,35-36.
A variety of research models have been used to study the ability of LGG to support healthy gut barrier function37-41. 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 system33,35-36,42.
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.
Nutramigen was introduced in 1942 and numerous clinical experiences with the formula have been recorded since that time. Several of these experiences are summarized below.
Studies conducted in healthy infants demonstrate that Nutramigen® promotes growth. In a 112-day growth study, 22 healthy male and female infants fed Nutramigen grew similar to historical control infants fed milk-based formula43. Metabolic balance studies were also conducted in male infants (mean age 7.7 months, n=6) who were recovering from malnutrition. The diet promoted adequate catch-up weight gain and maintained satisfactory serum albumin concentrations. Nitrogen absorption and retention were excellent. Fat and energy balances and stool characteristics were all within the expected normal ranges44. Additionally, Nutramigen with Enflora LGG has been demonstrated to support normal growth of healthy term infants45.
Safety and Tolerance
Because of the special characteristics of Nutramigen, it does not taste like cow's milk and soy-based formulas; however, most infants quickly adjust to the taste. A study evaluated infants' responses to Nutramigen as a novel food at 1-2 months of age or 7-8 months of age. Infants <2 months of age showed a slight reduction in intake of Nutramigen compared with their regular formula but continued to drink substantial and satiating amounts of Nutramigen. Older infants rejected the Nutramigen when it was offered. The investigators stated that acceptance of Nutramigen can be achieved in older infants, although not usually on the first presentation42. A clinical study demonstrated that healthy term infants tolerated Nutramigen with Enflora LGG especially well. The sources of DHA and ARA in Nutramigen are well tolerated. In clinical studies comparing infants fed formulas having DHA with infants fed formulas without DHA, there were no clinically significant differences in tolerance and the addition of DHA had no effect on the incidence of adverse events46-49. 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.50,51
1. Lothe L, Lindberg T. Cow’s milk whey protein elicits symptoms of infantile colic in colicky formula-fed infants: a double-blind crossover study. Pediatrics. 1989;83:262-266.
2. Baldassarre ME, Laforgia N, Fanelli M, et al. Lactobacillus GG improves recovery in infants with blood in the stools and presumptive allergic colitis compared with extensively hydrolyzed formula alone. J Pediatr. 2010;156:397-401.
3. Berni Canani R, Nocerino R, Terrin G, et al. Effect of Lactobacillus GG on tolerance acquisition in infants with cow’s milk allergy: a randomized trial. J Allergy Clin Immunol. 2012;129:580-582, 582 e1-5.
4. Berni Canani R, Di Costanzo M, Bedogni G, et al. Extensively hydrolyzed casein formula containing Lactobacillus rhamnosus GG reduces the occurrence of other allergic manifestations in children with cow’s milk allergy: 3-year randomized controlled trial. J Allergy Clin Immunol. 2017;139:1906-1913-e4. doi: 10.1016/j.jaci.2016.10.050.
5. Birch EE, Hoffman DR, Uauy R, et al. Visual acuity and the essentiality of docosahexaenoic acid and arachidonic acid in the diet of term infants. Pediatr Res. 1998;44:201-209.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. Brenna JT, Varamini B, Jensen RG, et al. Docosahexaenoic and arachidonic acid concentrations in human breast milk worldwide. Am J Clin Nutr. 2007;85:1457-1464.
14. Fomon SJ, Ziegler EE. Renal solute load and potential renal solute load in infancy. J Pediatr. 1999;134:11-14.
15. Fomon SJ, Ziegler EE. Renal solute load and potential renal solute load in infancy. J Pediatr. 1999;134:11-14.
16. Data on file, Mead Johnson Nutrition, May 1998.
17. Ziegler EE, Fomon SJ. Methods in infant nutrition research: balance and growth studies. Acta Paediatr Scand Suppl. 1982;299:90-96.
18. 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.
19. Isolauri E, Arvola T, Sütas Y, et al. Probiotics in the management of atopic eczema. Clin Exp Allergy. 2000;30:1604-1610.
20. Majamaa H, Isolauri E. Probiotics: a novel approach in the management of food allergy.?J Allergy Clin Immunol. 1997;99:179-185.
21. 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.
22. 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.
23. 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.
24. 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.
25. 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.
26. 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.
27. Koletzko B, Agostoni C, Carlson SE, et al. Long-chain polyunsaturated fatty acids (LC-PUFA) and perinatal development. Acta Paediatr. 2001;90:460-464.
28. Nutrient Requirements for Infant Formulas. Code of Federal Regulations 21, C.F.R. 107.100. April 1, 2006.
29. American Academy of Pediatrics, Committee on Nutrition. Iron fortification of infant formulas. Early Hum Dev. 1999;104:119-123.
30. 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.
31. 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.
32. 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.
33. Isolauri E, Arvola T, Sutas Y, et al. Probiotics in the management of atopic eczema. Clin Exp Allergy. 2000;20:1604-1610.
34. 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.
35. Majamaa H, Isolauri E. Probiotics: a novel approach in the management of food allergy. J Allergy Clin Immunol. 1997;99:179-185.
36. 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.
37. 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.
38. Mattar AF, Drongowski RA, Coran AG, et al. Effect of probiotics on enterocyte bacterial translocation in vitro. Pediatr Surg Int. 2001;17:265-268.
39. 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.
40. Lee DJ, Drongowski RA, Coran AG, et al. Evaluation of probiotic treatment in a neonatal animal model. Pediatr Surg Int. 2000;16:237-242.
41. 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.
42. 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.
43. Data on file, Mead Johnson Nutrition, July 1990.
44. Cordano A, Gastanaduy AS, Graham GG. Absorption and retention from an iso-osmolal casein hydrolysate infant formula. Nutrition Research. 1988;8:1353-1362.
45. Burks, W., S. M. Jones, et al. (2008). "Hypoallergenicity and effects on growth and tolerance of a new amino acid-based formula with docosahexaenoic acid and arachidonic acid." J Pediatr 153(2): 266-271
46. Mennella JA, Beauchamp GK. Developmental changes in the acceptance of protein hydrolysate formula. J Dev Behav Pediatr. 1996;17:386-391.
47. 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.
48. 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.
49. 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.
50. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition web site. Agency response letter GRAS Notice No. GRN 000041. Available at: http://www.cfsan.fda.gov/~rdb/opa-g041.html. Accessed April 19, 2007.
51. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition web site. Agency response letter GRAS Notice No. GRN 000080. Available at: http://www.cfsan.fda.gov/~rdb/opa-g080.html. Accessed April 19, 2007.
Letter of Medical Necessity for Nutramigen® with Enflora™ LGG®*
Insurance companies are not required to cover this product, but some do. This letter establishes a medical need for the product and might help get your patients' insurance company to reimburse them for the product.