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Safety, efficacy, and impact on gut microbial ecology of a Bifidobacterium longum subspecies infantis LMG11588 supplementation in healthy term infants: a randomized, double-blind, controlled trial in the Philippines.
Capeding, Maria Rosario Z; Phee, Loudhie Cyd M; Ming, Chang; Noti, Mario; Vidal, Karine; Le Carrou, Gilles; Frézal, A; Moll, Janne Marie; Vogt, Josef Korbinian; Myers, Pernille Neve; Nielsen, Bjørn Henrik; Boulangé, Claire L; Samuel, Tinu Mary; Berger, Bernard; Cercamondi, Colin Ivano.
Afiliación
  • Capeding MRZ; Asian Hospital and Medical Center, Muntinlupa City, Philippines.
  • Phee LCM; Asian Hospital and Medical Center, Muntinlupa City, Philippines.
  • Ming C; Biostatistics & Data, Nestlé Research, Lausanne, Switzerland.
  • Noti M; Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland.
  • Vidal K; Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland.
  • Le Carrou G; Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland.
  • Frézal A; Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland.
  • Moll JM; Clinical Microbiomics, Copenhagen, Denmark.
  • Vogt JK; Clinical Microbiomics, Copenhagen, Denmark.
  • Myers PN; Clinical Microbiomics, Copenhagen, Denmark.
  • Nielsen BH; Clinical Microbiomics, Copenhagen, Denmark.
  • Boulangé CL; Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland.
  • Samuel TM; Nestlé Product Technology Center - Nutrition, Société des Produits Nestlé S.A., Vevey, Switzerland.
  • Berger B; Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland.
  • Cercamondi CI; Nestlé Product Technology Center - Nutrition, Société des Produits Nestlé S.A., Vevey, Switzerland.
Front Nutr ; 10: 1319873, 2023.
Article en En | MEDLINE | ID: mdl-38162520
ABSTRACT

Introduction:

Bifidobacterium longum subspecies infantis (B. infantis) may play a key role in infant gut development. This trial evaluated safety, tolerability, and efficacy of B. infantis LMG11588 supplementation.

Methods:

This randomized, placebo-controlled, double-blind study conducted in the Philippines included healthy breastfed and/or formula-fed infants (14-21 days old) randomized for 8 weeks to a control group (CG; n = 77), or any of two B. infantis experimental groups (EGs) low (Lo-EG; 1*108 CFU/day; n = 75) or high dose (Hi-EG; 1.8*1010 CFU/day; n = 76). Primary endpoint was weight gain; secondary endpoints included stooling patterns, gastrointestinal symptoms, adverse events, fecal microbiome, biomarkers, pH, and organic acids.

Results:

Non-inferiority in weight gain was demonstrated for Hi-EG and Lo-EG vs. CG. Overall, probiotic supplementation promoted mushy-soft stools, fewer regurgitation episodes, and increased fecal acetate production, which was more pronounced in the exclusively breastfed infants (EBF) and positively correlated with B. infantis abundance. In EBF, fecal pro-inflammatory cytokines (IL-1 beta, IL-8) were reduced. Strain-level metagenomic analysis allowed attributing the increased abundance of B. infantis in EGs versus CG, to LMG11588 probiotic colonization. Colonization by autochthonous B. infantis strains was similar between groups.

Discussion:

B. infantis LMG11588 supplementation was associated with normal infant growth, was safe and well-tolerated and promoted a Bifidobacterium-rich microbiota driven by B. infantis LMG11588 colonization without disturbing the natural dispersal of autochthonous B. infantis strains. In EBF, supplementation stimulated microbial metabolic activity and beneficially modulated enteric inflammation.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials Idioma: En Revista: Front Nutr Año: 2023 Tipo del documento: Article País de afiliación: Filipinas Pais de publicación: Suiza
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials Idioma: En Revista: Front Nutr Año: 2023 Tipo del documento: Article País de afiliación: Filipinas Pais de publicación: Suiza