Lausanne, Switzerland, June 7, 2020 - Nestlé Health Science has presented new evidence from the CINNAMON study at the digital European Academy of Allergy and Clinical Immunology (EAACI) annual congress. The new data show that the addition of two Human Milk Oligosaccharides (HMO) to the whey-based, extensively hydrolyzed formula Althéra® reduces respiratory tract infections in infants with cow’s milk protein allergy (CMPA). Evidence presented in October 2019 from the same study confirmed that Althéra® with the two HMO supports normal growth and is well tolerated in infants with CMPA.
The CINNAMON trial compared Althéra®, supplemented with the two HMO, 2’fucosyl-lactose (2’FL) and lacto-N-neotetraose (LNnT)) and with a reduced protein content (2.2g/100kcal), to Althéra® without HMO and a higher protein content (2.5g/100kcal) in infants with CMPA. The primary outcome was growth (weight gain), whilst secondary outcomes included gastrointestinal tolerance, control of allergic symptoms, as well as the rate and frequency of respiratory tract infections.
The IVORY trial (published in June 2019), the first ever study for specialty infant formula supplemented with the two HMO, had already confirmed the safety and hypoallergenicity of the HMO in infants with CMPA.1
HMO are non-digestible, complex carbohydrates which make up the third largest solid component in breast milk, after lactose and lipids. 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, and this blend of breast milk-identical HMO developed by Nestlé.
CMPA is an immune-mediated disease characterized by allergic reactions to cow’s milk protein. This is associated with increased gut permeability and an altered gut microbiota which impacts the maturation of the immune system and may increase the risk of infections during infancy. The CINNAMON study documented the rate and frequency of upper and lower respiratory tract infections (URTI, LRTI) during the study from enrolment to 12 months of age. The study confirms the immune-modulating benefits of Nestlé’s HMO blend, as a reduction in respiratory infections was seen in infants consuming the HMO-supplemented formula. Specifically, there was a significant reduction in the frequency of URTI episodes by more than 40% from the time of enrolment to 12 months of age, compared to infants receiving the control formula without HMO.
These data support 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, which found a lower risk of respiratory tract infections and medication use. Notably, there was a 55% and 53% significantly lower risk for LRTI and antibiotic use, respectively.
CMPA impacts up to 3% of infants and is associated with digestive, skin, respiratory and other symptoms. CMPA is an immune-mediated disease, and therefore infants with CMPA who cannot be breastfed may benefit from the immune-modulating properties of HMO.
Professor of Pediatrics Anna Nowak-Wegrzyn , Allergy and Immunology, Department of Pediatrics, Hassenfeld Children's Hospital, NYU Langone Health, New York, who presented some of the data at the EAACI annual congress said, “HMO are critical to the support of an infant’s immune system, particularly in those with CMPA as they are more susceptible to infections. ” HMO support the establishment of beneficial bacteria in the gut, where they modulate the immune system. They eliminate some pathogens through a decoy effect, while also strengthening the gut barrier and guiding the maturation of the immune system. The benefits seen by providing the two HMO, 2’FL and LNnT, which include a reduction of URTI, LRTI and also related medication use, as well as a lower protein intake to infants with CMPA that for any reason cannot be breastfed, further advances the management of CMPA.”
Nestlé Health Science is committed to HMO research in infants with CMPA. It has recently launched the extensively hydrolyzed (Althéra® and Alfaré®) and amino acid-based (Alfamino®) formula portfolio with 2’FL and LNnT for the management of CMPA. Product launches have commenced in Mexico, France and Germany with further launches planned in 2020.
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.
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.
1. Vandenplas Y et al. Extensively hydrolyzed formula with two human milk oligosaccharides reduces rate of upper respiratory tract infections in infants with cow’s milk allergy. Late-breaking oral abstract presentation at EAACI Digital Congress. Presented at the EAACI Digital Congress. June 6-8, 2020 (CINNAMON Study).
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. Oral abstract presentation at EAACI-PAAM. Florence, Italy. October 19, 2019 (CINNAMON Study).
3. 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).
4. Human Milk Oligosaccharides: New Ways to Shape the Gut Microbiome in Cow’s Milk Protein Allergy. Nestlé Health Science Symposia Proceedings from the EAACI Annual Scientific Meeting 2019. European Medical Journal Allergy & Immunology 2019;4:48-54.
5. 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