THE IVORY TRIAL

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.