Dans cet essai randomisé multicentrique, les nourrissons (≤12 mois) ont reçu soit Althéra® HMO (n=97) soit Althéra® (n=97) jusqu'à ce qu'ils atteignent l'âge de 12 mois.
Principaux résultats: L'ajout d'oligosaccharides de lait humain (HMO) 2'FL et LNnT a semblé corriger la dysbiose intestinale du microbiome causée par l’APLV. On a constaté une augmentation des bifidobactéries de type infantile et une diminution des bactéries nocives, y compris des protéobactéries.
Reference: Boulangé CL, Pedersen HK, Martin FP, Siegwald L, Pallejà Caro A, Eklund AC, Jia W, Zhang H, Berger B, Sprenger N, Heine RG, Cinnamon Study Investigator Group. An Extensively Hydrolyzed Formula Supplemented with Two Human Milk Oligosaccharides Modifies the Fecal Microbiome and Metabolome in Infants with Cow's Milk Protein Allergy. Int J Mol Sci. 2023 Jul 13;24(14):11422. doi: 10.3390/ijms241411422.
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CINNAMON STUDY: AN EXTENSIVELY HYDROLYZED FORMULA SUPPLEMENTED WITH TWO HUMAN MILK OLIGOSACCHARIDES MODIFIES THE FECAL MICROBIOME AND METABOLOME IN INFANTS WITH COW’S MILK PROTEIN ALLERGY
Boulangé CL et al. Int J Mol Sci. 2023 Jul 13;24(14):11422.
Study objectives
To evaluate the effects of Althéra® HMO, an extensively hydrolyzed formula (EHF) supplemented with two human milk oligosaccharides (HMO:2’-Fucosyllactose [2’- FL] and Lacto-N-neotetraose [LNnT]) on the fecal microbial ecosystem in infants with CMPA. This was part of the original CINNAMON (Vandenplas 2022) was to assess growth and the effects of HMOs on infection rates.
Subjects and methods
Multicenter, randomized, controlled, double-blind clinical trial, comparing two parallel infant groups.
- Infants aged 0–6 months with CMPA were randomized to receive a lactose-containingEHF, with1.0 g/L of 2′-FL& 0.5 g/L of LNnT( Althéra® HMO)orwithoutHMO (control, Althéra®)
- Stool samples were collected at baseline (Visit 0), 1 month (Visit 1), 3 months (Visit 3), and 12 months (Visit 6).
- Infants were stratified into early (0-3 months) and late (3-6 months) enrollment groups to reduce the confounding effects of age and complementary diet.
Endpoints
- Microbiome composition and fecal metabolomic signature were analyzed using shotgun metagenomics and targeted mass spectrometry.
- The development of the infant’s microbiome was monitored over time by tracking 5 fecal community types (FCT) - samples with similar microbiome composition.
Results
Feeding with an HMO-supplemented hypoallergenic formula containing 2ʹ-FL and LNnT in infants with CMPA partially corrected the intestinal microbial dysbiosis by enriching infant-type bifidobacteria, and reducing the abundances of other harmful bacteria such as proteobacteria.
Supplementation with 2’-FL and LNnT delayed the transition of the microbiome composition towards an adultlike pattern (FCT5), which may prolong the window period for early immune modulation.
There was an early increase in acetate production in the HMO group, whereas in the control group, acetate decreased.
There was a major shift in microbiome composition and metabolome profile at around 6 months of age, due to the effects of complementary diet and increased bacterial fermentation of dietary fibre.
- HMOs shape the microbiome composition for this transition and promote healthy early immune development.
Conclusion
- 2ʹ-FL and LNnT supplemented in hypoallergenic formula partially corrected the intestinal microbial dysbiosis.
- 2ʹ-FL and LNnT contributed to a healthier, age-appropriate gut microbiome and promoted immune-modulatory effects, including a lower rate of respiratory tract infections and otitis media.
