In deze multicenter gerandomiseerde studie kregen zuigelingen (≤12 maanden) ofwel Althéra® HMO (n=97) ofwel Althéra® (n=97) aangeboden tot ze een leeftijd van 12 maanden bereikten.
Belangrijkste resultaten: In beide groepen werd een normale groei en een vermindering van de KMA symptomen gevonden. Daarnaast werd er in de Althéra® HMO groep een significante vermindering (p<0,05) gevonden van de bovenste luchtweg infecties. Er was bovendien ook een vermindering te zien in het aantal lagere luchtweginfecties, oor infecties en gastro-intestinale infecties.
In onderstaande infographic kunt u zelf de highlights van de studie nalezen.
Referentie: Vandenplas Y, Żołnowska M, Berni Canani R, Ludman S, Tengelyi Z, Moreno-Álvarez A, Goh AEN, Gosoniu ML, Kirwan BA, Tadi M, Heine RG, Cinnamon Study Investigator Group. Effects of an Extensively Hydrolyzed Formula Supplemented with Two Human Milk Oligosaccharides on Growth, Tolerability, Safety and Infection Risk in Infants with Cow's Milk Protein Allergy: A Randomized, Multi-Center Trial. Nutrients. 2022 Jan 26;14(3):530. doi: 10.3390/nu14030530.
CINNAMON STUDY: GROWTH, TOLERANCE AND SAFETY OF AN EXTENSIVELY HYDROLYZED FORMULA CONTAINING TWO HUMAN MILK OLIGOSACCHARIDES IN INFANTS WITH COW’S MILK PROTEIN ALLERGY
Vandenplas Y et al. Nutrients. 2022 Jan 26;14(3):530.
Study objectives
To evaluate if an extensively hydrolyzed formula (eHF) supplemented with two human milk oligosaccharides (HMO; 2’-Fucosyllactose [2’-FL] and Lacto-N-neotetraose [LNnT]), with a reduced protein content, supports normal growth and is well tolerated in infants with cow’s milk protein allergy (CMPA).
Subjects and methods
Multicenter, randomized study included infants with CMPA who received a whey-based eHF with 1.0 g/L 2’-FL and 0.5 g/L LNnT (Althéra® HMO) (n=97) or a commercially available whey-based eHF without HMO (Althera®) (n=97), as control formula. Infants were followed to 12 months of age.
Endpoints
Daily weight gain from baseline (V0) to 4 months (V4) and 12 months (V6) (primary endpoint). Weight-for-age, lengthfor- age and head circumference-for-age Z-scores, clinical tolerance and efficacy (Cow’s Milk-related Symptom Scores; CoMiSS®), rates of adverse events and medication use until 12 months of age (secondary endpoints).
Results
- Non-inferior daily weight gain was shown for Althéra® HMO from V0 to V4 vs. Althera® without HMO (19.38g/d vs. 20.12g/d; p=0.0049)
- There were no significant group differences for any of the anthropometric parameters at any study time point
- Althéra® HMO was well tolerated and mean CoMiSS® scores were significantly reduced from 12.1 to 3.4 (p<0.001; V0 to V1)
- Number of adverse events was similar between groups
- The frequency of upper respiratory tract infections was significantly reduced (p<0.05), while a trend toward a reduction in the rate of respiratory tract infections, otitis media, gastrointestinal infections as well as the use of antibiotics and antipyretics was reported in those consuming Althéra® HMO
- A significant 100% reduction was observed for otitis media in the per protocol group (p<0.05) consuming Althéra® HMO
Conclusion
Infants with CMPA fed Althéra® HMO, with a reduced protein content, achieved symptom relief and normal growth. A reduction of respiratory tract, ear and gastrointestinal infections was observed, as well as a lower use of associated medication.
