Nestlé Health Science has presented evidence from the IVORY trial proving that the whey-based extensively hydrolysed formula (SMA® Althéra®) containing two Human Milk Oligosaccharides (HMOs) is suitable for infants with Cows' Milk Allergy (CMA)

06 June 2019, Epalinges, Switzerland.

The data was presented at the annual congress of European Academy of Allergy and Clinical Immunology (EAACI) in Lisbon on June 4, 2019. It is the first ever trial testing an eHF supplemented with HMO: 2’fucosyl-lactose (2’FL) and lacto-N-neotetraose (LNnT), a specific blend developed by Nestlé.1

The trial assessed a whey-based extensively hydrolyzed specialty formula (eHF) for the management of CMA supplemented with two HMOs for clinical hypoallergenicity and safety. The whey-based eHF study formula (SMA® Althéra®) was supplemented with 2’FL and LNnT. It was shown to be tolerated by 98% of infants and children with CMA, confirming hypoallergenicity according to the criteria set by the American Academy of Pediatrics (AAP).1,2 Learn more about the IVORY trial here.

Data has now also been presented at the bi-annual Pediatric Allergy & Asthma Meeting (PAAM) in Florence, Italy on October 19 on the CINNAMON study, the second trial testing the extensively hydrolysed formula (EHF), SMA® Althéra®, supplemented with the two HMO, 2’fucosyl-lactose (2’FL) and lacto-N-neotetraose (LNnT). Learn more about the CINNAMON study here.

HMOs are non-digestible carbohydrates which make up the third largest solid component in breast milk, after lactose and lipids. While protective benefits of HMOs have been investigated for several decades, the production of breast milk-identical HMOs has only recently become technically feasible.

The positive role of HMOs is highlighted by Professor Anna Nowak-Wegrzyn of the Icahn School of Medicine at Mount Sinai in New York, USA who led the trial that confirmed hypoallergenicity in the whey-based eHF. “HMOs are complex, unconjugated glycans abundant in human milk. HMOs survive in the GI tract and influence colonic microbiota. HMOs bind to surface receptors on the gut epithelial and immune cells, and act as soluble decoy receptors to block the attachment of pathogenic microbes to cells.” The addition of the two HMOs has previously been shown to reduce the risk of viral and bacterial infections associated with diarrhoea and respiratory diseases in healthy infants.4,5,6

CMA impacts up to 3% of infants and is associated with digestive, skin, respiratory and other symptoms.7 It is known to compromise the gut microbiome. Breastfeeding is the best way to feed an infant with CMA, however in infants with CMA that cannot be breast-fed, they may therefore benefit from the gut modulating properties of added HMOs.

Professor Herald Renz, from Philipps University Marburg, Germany spoke at the Satellite Symposium at EACCI, at which the trial results were discussed. He highlighted the importance of addressing the microbiome in early immune development and allergies. “The establishment of a stable gut microbial community closely tracks host growth and immune development. Delayed or altered establishment of microbial communities leads to microbiome immaturity, which has been associated with an increased risk of allergies, including food allergies. Nutritional strategies to support microbiome development may complement the existing treatment of CMA.”

Nestlé Health Science is committed to HMO research in infants with CMA. SMA® Althéra® and SMA® Alfamino® with 2’FL and LNnT will be the only products for the management of CMA with two of the most significant HMOs.

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.

1. Hypoallergenicity of a whey-based, extensively hydrolysed infant formula containing two human milk oligosaccharides: Anna Nowak-Wegrzyn, Laura Czerkies, Kemuel Reyes, Barbara Collins, Ralf G. Heine. Abstract presented at the annual EAACI congress in Lisbon June 1-5, 2019.
2. American Academy of Pediatrics. Committee on Nutrition. Hypoallergenic infant formulas. Pediatrics. 2000, 106. 346-9.
3. Nowak-Wegrzyn A, Czerkies L, Kuslys M, et al. Allergy 2019 Mar 21. doi: 10.1111/all.13780. Letter to the editor. Epub ahead of print. 4. L. Bode: Human milk oligosaccharides: every baby needs a sugar mama. In: Glycobiology. Band 22, Nummer 9, September 2012, S. 1147–1162.
5. D. S. Newburg, Y. He: Neonatal Gut Microbiota and Human Milk Glycans Cooperate to Attenuate Infection and Inflammation. In: Clinical obstetrics and gynecology. Band 58, Nummer 4, December 2015, S. 814–826.
6. Ballard O, Morrow AL. Human milk composition: nutrients and bioactive factors. Pediatr Clin North Am 2013;60:49-74.
7. Høst A. Frequency of cow’s milk allergy in childhood. Ann Allergy Asthma Immunol 2002;89(Sup1):33-7.


*HMOs: structurally identical Human Milk Oligosaccharides, not sourced from breast milk.