Bifidobacterium and Lactobacillus Probiotics and Gut Dysbiosis in Preterm Infants: The PRIMAL Randomized Clinical Trial
Van Rossum T, Haiss A, Knoll RL, Marissen J, Podlesny D
Published in JAMA Pediatrics
Methodology
Multicentre, double-blinded, placebo-controlled phase 3 trial at 18 German neonatal units giving 28 days of B. longum subsp. infantis, B. lactis BB-12 and L. acidophilus La-5 to infants born at 28-32 weeks; primary endpoint was multidrug-resistant organism colonisation at day 30.
Key Findings
The probiotic did not reduce colonisation with multidrug-resistant or highly epidemic organisms at day 30, although it shifted the gut microbiome toward the eubiotic profile of healthy term infants.
Conclusions
Multistrain probiotic supplementation shaped the preterm microbiome but did not meet its primary clinical colonisation endpoint.
Limitations
Recruitment stopped early on interim results; multistrain product; microbiome endpoints are surrogate rather than clinical.
Supplements Studied
Probiotics did not prevent colonization with multidrug-resistant organisms or highly epidemic bacteria at day 30 of life.
Outcomes Measured
Probiotics shaped the microbiome of preterm infants toward the eubiotic state of healthy full-term infants.
Study Details
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Disclosures
Funding
Public/academic funding
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