Nestlé’s Human Milk Oligosaccharide blend positively shapes the gut microbiome of infants with Cow’s Milk Protein Allergy

Lausanne, Switzerland [17 October 2020] -- Nestlé Health Science and Clinical Microbiomics (Copenhagen, Denmark) presented new evidence from the CINNAMON study at the FAAM-EUROBAT Digital 2020 Meeting. The new data show that the addition of two Human Milk Oligosaccharides (HMO; 2’fucosyl-lactose (2’FL) and lacto-N-neotetraose (LNnT)) to the whey-based, extensively hydrolyzed formula, Althéra®, positively shapes the gut microbiome of infants with cow’s milk protein allergy (CMPA). Evidence presented previously confirmed that Althéra® with the two HMO is safe, hypoallergenic, reduces respiratory tract infections, supports normal growth and is well tolerated in infants with CMPA.^1-4
 
HMO are non-digestible, complex carbohydrates which make up the third largest solid component in breast milk, after lactose and lipids.⁵ While protective benefits of HMO have been recognized for several decades, the production of breast milk-identical HMO has only recently become technically feasible. 2’FL and LNnT are two of the most significant HMO in breast milk,⁵ and this blend of breast milk-identical HMO was developed by Nestlé. 
 
CMPA is an immune-mediated disease characterized by allergic reactions to cow’s milk protein.⁶  It affects up to 3% of infants and is associated with digestive, skin, respiratory and other symptoms.⁶ Infants with CMPA also have disturbed gastrointestinal microbiota (dysbiosis), with a reduced presence of beneficial bacteria, such as Bifidobacteria.^7-8 As an estimated 70% of all immune cells reside in the gut and closely interact with the gut microbiome,⁶ the dysbiosis in infants with CMPA is thought to delay immune maturation and contribute to a higher risk for infections and future allergies.^5,9-11 

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The CINNAMON study assessed fecal microbial composition during the study from enrolment to 12 months of age. The study confirms the microbiome-modulating benefits of Nestlé’s HMO blend, as infants fed HMO-supplemented formula had a lower microbial diversity and reduced gut microbiota age at 12 months of age, with higher counts of Bifidobacteria.¹² HMO supplementation thus appeared to slow the premature shift towards an adult-type gut microbiome previously described in infants receiving no or only some breast milk.^12-14 This change in the microbiome may explain the observed reduction in respiratory infections.^2,3,12 
 
The data supports previous findings from another Nestlé-sponsored clinical trial with standard infant formula, supplemented with the same blend of two HMO (2’FL and LNnT) in healthy infants. In that study, the gut microbiota shifted closer to that of healthy breastfed infants.¹⁵ Notably, this was linked to significantly fewer lower respiratory tract infections and lower use of antibiotics.^15,16  
 
“Based on published data from breastfed and non-breastfed infants, a premature shift towards an adult-type microbiome is undesirable in the first year of life”^13-14 explained Dr Ralf Heine, Global Medical Director in Pediatric Allergy at Nestlé Health Science. “Data from our study show that HMO have the ability to significantly shape the microbiome of infants with CMPA, with patterns closer to those seen in breastfed infants, which may translate into tangible clinical benefits.”¹² 
 
Professor Anna Nowak-Wegrzyn, Department of Pediatrics, Hassenfeld Children’s Hospital, NYU, USA, who presented data from the CINNAMON Study at the Nestlé Health Science sponsored symposium at FAAM-EUROBAT Digital 2020 said, “Infants with CMPA, particularly those that are not breastfed, are at an increased risk of respiratory infections. Supplementing specialty formula for infants with CMPA with two HMO was associated with a reduction of respiratory tract infections and it is a significant advance in the management of CMPA.^2-3 These clinical benefits are likely due to positive effects of the microbiome on early immune development.”^12,15,16  
 
Nestlé Health Science is committed to HMO research in infants with CMPA.  It has recently launched the extensively hydrolyzed (Althéra® HMO and Alfaré® HMO) and amino acid-based (Alfamino® HMO) formula portfolio with 2’FL and LNnT for the management of infants with CMPA. Product launches have commenced in Europe, the Middle East, Central America and South America, with further launches planned.  

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IMPORTANT NOTICE: Mothers should be encouraged to continue breastfeeding even when their infants have cow’s milk protein allergy. This usually requires qualified dietary counseling to completely exclude all sources of cow’s milk protein from the mothers’ diet. If a decision to use a special formula intended for infants is taken, it is important to give instructions on correct preparation methods, emphasizing that unboiled water, unsterilized bottles, or incorrect dilution can all lead to illness. Formula for special medical purposes intended for infants must be used under medical supervision. 

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Nestlé Health Science (NHSc), a wholly-owned subsidiary of Nestlé, is a globally recognized leader in the field of nutritional science. At NHSc we are committed to empowering healthier lives through nutrition for consumers, patients and their healthcare partners. We offer an extensive consumer health portfolio of industry-leading medical nutrition, consumer and VMS brands that are science-based solutions covering all facets of health from prevention, to maintenance, all the way through to treatment. NHSc is redefining the way we approach the management of health in several key areas such as pediatric health, allergy, acute care, oncology, metabolic health, healthy aging, gastrointestinal health, and inborn errors of metabolism. Headquartered in Switzerland, NHSc employs over 5’000 people around the world, who are committed to making a difference in people’s lives, for a healthier today and tomorrow.  
Media contact: Paola.Mauroni1@nestle.com 
 
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REFERENCES 

1.    New Advances in the Prevention and Management of Food Allergy. Nestlé Health Science Symposia Proceeding from EAACI Digital 2020. Eur Med J Allergy Immunol 2020;5:28-36. 
2.    Vandenplas Y, et al Growth tolerance and safety of an extensively hydrolyzed formula containing two human milk oligosaccharides in infants with cow’s milk protein allergy. Abstract presented at EAACI-PAAM, Florence, Italy. October 17-19, 2019 (CINNAMON Study). 
3.    Vandenplas Y et al. Extensively hydrolysed formula with two human milk oligosaccharides reduces rate of upper respiratory tract infections in infants with cow’s milk allergy. Abstract presented at EAACI Digital. June 6-8, 2020 (CINNAMON Study). 
4.    Nowak-Wegrzyn A et al. Confirmed hypoallergenicity of a novel whey-based extensively hydrolyzed infant formula containing two human milk oligosaccharides. Nutrients 2019;11:1447. (IVORY Study). 
5.    Human Milk Oligosaccharides, New Ways to Shape the Gut Microbiome in Cow’s Milk Protein Allergy. Nestlé Health Science Symposia Proceedings from EAACI 2019. Eur Med J Allergy Immunol 2019;4:48-54. 
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8.    Francavilla R et al. Effect of lactose on gut microbiota and metabolome of infants with cow's milk allergy. Pediatr Allergy Immunol 2012;23:420-427.  
9.    Woicka-Kolejwa K et al. Food allergy is associated with recurrent respiratory tract infections during childhood. Postepy Dermatol Alergol 2016;33:109-13. 
10.    Juntti H et al. Cow's milk allergy is associated with recurrent otitis media during childhood Acta Otolaryngol 1999;119:867-73. 
11.    Tikkanen S et al. Status of children with cow's milk allergy in infancy by 10 years of age Acta Paediatr 2000;89:1174-80. 
12.    Pedersen H et al. An extensively hydrolysed formula supplemented with two human milk oligosaccharides (HMO) shapes the gut microbiome in infants with cow’s milk protein allergy (CMPA). Abstract presented at FAAM-EUROBAT Digital 2020. October 16-17, 2020. 
13.    Stewart CJ et al. Temporal development of the gut microbiome in early childhood from the TEDDY study. Nature 2018;562:583–8. 
14.    Ho NT et al. Meta-analysis of effects of exclusive breastfeeding on infant gut microbiota across populations. Nature Communications 2018;9:4169. 
15.    Berger B, et al. Linking Human Milk Oligosaccharides, Infant Fecal Community Types, and Later Risk To Require Antibiotics. mBio 2020;11:e03196-19. 
16.    Puccio G et al. Effects of infant formula with human milk oligosaccharides on growth and morbidity: A randomized multicenter trial. J Pediatr Gastroenterol Nutr 2017;64:624-631.