Probiotics and the EARly Life effects on intestinal bacteria and inflammation in children with Cystic Fibrosis (The PEARL-CF Study)

The role of probiotics in children with cystic fibrosis (CwCF) remains unclear. The PEARL-CF study was an international, double-blind, randomized, placebo-controlled study involving CwCF (0-6 years), and assessed the effects of a probiotic on intestinal microbiota and clinical outcomes. A multi-strain probiotic (15 Lactobacillus/Bifidobacterium strains; [~]2-3x1010 CFU daily) or placebo was administered for 12-months and participants followed a further 12-months post-intervention. Among 77 CwCF (38 probiotic, 39 placebo), bacterial alpha diversity did not differ between groups. Participants [≥]4 years on probiotic demonstrated higher bacterial richness (post-hoc analysis). Haemophilus influenzae was less prevalent in clinically indicated respiratory swabs in the probiotic cohort during the intervention (27% vs 56%; p=0.03), especially when commenced prior to 4 years old. Fecal M2-pyruvate kinase decreased in the probiotic cohort from baseline to 12 months. This study provides support for multi-strain probiotics in CwCF, even in the era of modulator therapy.