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: De toevoeging van Humane Melk Oligosacchariden (HMO) 2’FL en LNnT lijken te corrigeren voor de intestinale dysbiose van het microbioom die is ontstaan door de KMA. Er werd een verhoging van de “infant-type” bifidobacteria gevonden en een verlaging van de schadelijke bacteriën waaronder de proteobacterie.

_{^{Referentie: 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.}}

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.

Tijdens het ISICEM congress in Brussel zijn wij aanwezig met een stand en is er op 21 maart het lunch symposium: Challenges on the road to Personalized Nutrition. Dr. Jean-Charles Preiser zal het symposium voorzitten en Prof. Dr. Arthur van Zanten en Dr. Juan B. Ochoa Gautier zullen hun inzichten omtrent gepersonaliseerd voeden op de IC delen.

Programma: Challenges on the road to Personalized Nutrition.

ISICEM 2023 Symposium: Challenges On The Road To Personalized Nutrition:

ISICEM 2023 Symposium - Prof. Dr. Arthur van Zanten:

ISICEM 2023 Symposium - Dr. Juan Ochoa Gautier:

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.