Fermented infant formula (with Bifidobacterium breve C50 and Streptococcus thermophilus O65) with prebiotic oligosaccharides is safe and modulates the gut microbiota towards a microbiota closer to that of breastfed infants
Autor: | Jan Knol, Mieke Roelofs, Dominique Turck, Gaetano Chirico, Raish Oozeer, Thameur Rakza, Guus Roeselers, Sebastian Tims, Laurent Béghin, Jean-Christophe Rozé, Carole Rougé |
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Jazyk: | angličtina |
Rok vydání: | 2021 |
Předmět: |
0301 basic medicine
Male Streptococcus thermophilus medicine.medical_treatment ved/biology.organism_classification_rank.species Breastfeeding Physiology Oligosaccharides Gut flora Bifidobacterium breve Critical Care and Intensive Care Medicine Feces 0302 clinical medicine Microbiologie Bifidobacterium Nutrition and Dietetics biology Infant Formula Breast Feeding Secretory IgA Female Fermented Foods Early-life microbiota 030209 endocrinology & metabolism Microbiology 03 medical and health sciences Double-Blind Method medicine Humans Microbiome MolEco VLAG 030109 nutrition & dietetics Bacteria ved/biology business.industry Prebiotic Infant Postbiotics biology.organism_classification Gastrointestinal Microbiome Prebiotics Infant formula Fermentation Immunoglobulin A Secretory Fermented formula Healthy term infants business |
Zdroj: | Clinical Nutrition, 40(3), 778-787 Clinical Nutrition 40 (2021) 3 |
ISSN: | 0261-5614 |
Popis: | Summary Background & aims Microbiome-modulators can help positively steer early-life microbiota development but their effects on microbiome functionality and associated safety and tolerance need to be demonstrated. We investigated the microbiome impact of a new combination of bioactive compounds, produced by the food-grade microorganisms Bifidobacterium breve C50 and Streptococcus thermophilus ST065 during a fermentation process, and prebiotics in an infant formula. Tolerance and safety were also assessed. Methods An exploratory prospective, randomized, double-blind, controlled, multi-centre study was designed to investigate the effect of bioactive compounds and prebiotics (short-chain galacto-oligosaccharides (scGOS)/long-chain fructo-oligosaccharides (lcFOS) 9:1). Experimental formulas containing these bioactive compounds and prebiotics (FERM/scGOS/lcFOS), prebiotics (scGOS/lcFOS), or bioactive compounds (FERM), were compared to a standard cow's milk-based control formula (Control). Exclusively breastfed infants were included as a reference arm since exclusive breastfeeding is considered as the optimal feeding for infants. The study lasted six months and included visits to health care professionals at baseline, two, four and six months of age. Stool SIgA concentration was the primary study outcome parameter. Results There were 280 infants randomized over the experimental arms and 70 infants entered the breastfed-reference arm. Demographics were balanced, growth and tolerance parameters were according to expectation and adverse events were limited. At four months of age the median SIgA concentration in the FERM/scGOS/lcFOS group was significantly higher compared to the Control group (p = 0.03) and was more similar to the concentrations found in the breastfed-reference group. Bifidobacterium increased over time in all groups. The FERM/scGOS/lcFOS combination resulted in a microbiota composition and metabolic activity closer to the breastfed infants’ microbiome. Conclusion The FERM/scGOS/lcFOS combination showed a significant positive effect on SIgA levels. All formulas tested were associated with normal growth and were well-tolerated. Additionally, at four months of age the FERM/scGOS/lcFOS formula brought the microbiome composition and metabolic activity closer towards that of breastfed infants. Clinical trial registry Registration number NTR2726 (Netherlands Trial Register; www.trialregister.nl/ ). |
Databáze: | OpenAIRE |
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