Safety and tolerance of infant formulas containing probiotics: a multicenter, randomized, controlled trial in healthy term infants DOI
M. Mitra,

Audrey Petitjean,

Ritesh Agrawal

et al.

medRxiv (Cold Spring Harbor Laboratory), Journal Year: 2025, Volume and Issue: unknown

Published: April 29, 2025

Abstract Several studies have documented the safety and tolerance of probiotics in infants, however, most are conducted with supplement. This randomized, double-blind, multicenter trial evaluated growth healthy term infants fed infant formula supplemented Limosilactobacillus reuteri DSM17938 ( L. ; n=92) or Bifidobacterium lactis CNCM I-3446 (B. n=92 ) same without (n=95). Mixed feeding breast milk was allowed each group. Exclusively breastfed (n=100) were included for reference. Non-inferiority weight gain (margin −3 g/day) from enrollment to age 6 months primary outcome. Length, BMI, head circumference, WHO z -scores birth 12 assessed, as digestive tolerance, and, a subset urinary D-lactate parameters stool microbiota composition. Of 279 256 completed study. The mean difference between probiotic group standard at −0.378 g/day (97.5% confidence interval [CI], −1.541, 0.776; P <0.001) −1.724 CI, −2.845, −0.603; =0.005) B. , indicating non-inferior growth. Anthropometric not significantly different any formulas, over entire study, except slightly lower weight-for-age -score vs. 8 =0.034). No differences adverse events levels observed. Significantly higher fecal Lactobacilli counts observed supplementation (7.0 log10[CFU/g]; n=24) compared (6.2 n=21). Parent-reported symptoms similar among groups comparable Weight Indian containing versus probiotics. Both formulas safe well-tolerated. Trial registration CTRI/2010/091/001111 (Clinical Trials Registry - India; www.ctri.nic.in

Language: Английский

Safety and tolerance of infant formulas containing probiotics: a multicenter, randomized, controlled trial in healthy term infants DOI
M. Mitra,

Audrey Petitjean,

Ritesh Agrawal

et al.

medRxiv (Cold Spring Harbor Laboratory), Journal Year: 2025, Volume and Issue: unknown

Published: April 29, 2025

Abstract Several studies have documented the safety and tolerance of probiotics in infants, however, most are conducted with supplement. This randomized, double-blind, multicenter trial evaluated growth healthy term infants fed infant formula supplemented Limosilactobacillus reuteri DSM17938 ( L. ; n=92) or Bifidobacterium lactis CNCM I-3446 (B. n=92 ) same without (n=95). Mixed feeding breast milk was allowed each group. Exclusively breastfed (n=100) were included for reference. Non-inferiority weight gain (margin −3 g/day) from enrollment to age 6 months primary outcome. Length, BMI, head circumference, WHO z -scores birth 12 assessed, as digestive tolerance, and, a subset urinary D-lactate parameters stool microbiota composition. Of 279 256 completed study. The mean difference between probiotic group standard at −0.378 g/day (97.5% confidence interval [CI], −1.541, 0.776; P <0.001) −1.724 CI, −2.845, −0.603; =0.005) B. , indicating non-inferior growth. Anthropometric not significantly different any formulas, over entire study, except slightly lower weight-for-age -score vs. 8 =0.034). No differences adverse events levels observed. Significantly higher fecal Lactobacilli counts observed supplementation (7.0 log10[CFU/g]; n=24) compared (6.2 n=21). Parent-reported symptoms similar among groups comparable Weight Indian containing versus probiotics. Both formulas safe well-tolerated. Trial registration CTRI/2010/091/001111 (Clinical Trials Registry - India; www.ctri.nic.in

Language: Английский

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