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Effect of Bifidobacterium animalis subsp lactis Supplementation in Preterm Infants: A Systematic Review of Randomized Controlled Trials

  • 2010-08
  • Journal of Pediatric Gastroenterology and Nutrition 51(2)
    • H. Szajewska
    • S. Guandalini
    • L. Morelli
    • J. V. van Goudoever
    • A. Walker

Abstract

Objective: To systematically evaluate and update evidence on the efficacy and safety of Bifidobacterium animalis subsp lactis CNCM I-3446 supplementation in preterm infants.

Materials and methods: The Cochrane Library and MEDLINE databases and major pediatric conference proceedings were searched in December 2008 for randomized controlled trials (RCTs). The company that manufactures B lactis was contacted for unpublished data. The review was restricted to RCTs performed in preterm infants <37 weeks of gestation and/or with a birth weight <2500 g.

Results: Four RCTs involving 324 infants met the inclusion criteria. Compared with controls, B lactis supplementation has the potential to increase fecal bifidobacteria counts and to reduce Enterobacteriaceae and Clostridium spp counts. It also can reduce stool pH and fecal calprotectin concentrations, increase fecal immunoglobulin A and short-chain fatty acid concentrations, and decrease intestinal permeability. Compared with controls, B lactis supplementation had no effect on the risk of necrotizing enterocolitis stage > or = 2 (3 RCTs, n = 293, risk ratio [RR] 0.53, 95% CI 0.16-1.83), risk of sepsis (2 RCTs, 397 cultures, RR 0.6, 95% CI 0.07-5.2), and use of antibiotics (2 RCTs, n = 255, RR 0.67, 95% CI 0.28-1.62). The power of these studies, however, does not allow for a definitive statement regarding a reduced risk of necrotizing enterocolitis. B lactis supplementation did have some effects on anthropometric parameters. No adverse events associated with B lactis supplementation were reported.

Conclusions: Evidence regarding the potential beneficial effects of B lactis supplementation in preterm infants is encouraging. Further studies to assess clinically relevant outcomes are needed.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Bifidobacterium animalis subsp. lactisIncreased Fecal Bifidobacteria LevelsBeneficial
Moderate
Bifidobacterium animalis subsp. lactisIncreased Fecal Immunoglobulin A ConcentrationsBeneficial
Moderate
Bifidobacterium animalis subsp. lactisIncreased Short Chain Fatty AcidsBeneficial
Moderate
Bifidobacterium animalis subsp. lactisNo Adverse Events ObservedNeutral
Small
Bifidobacterium animalis subsp. lactisNo Change in Antibiotic UsageNeutral
Small
Bifidobacterium animalis subsp. lactisNo Change in Risk of Necrotizing EnterocolitisNeutral
Small
Bifidobacterium animalis subsp. lactisNo Change in Sepsis RiskNeutral
Small
Bifidobacterium animalis subsp. lactisReduced Body Mass IndexBeneficial
Moderate
Bifidobacterium animalis subsp. lactisReduced Faecal CalprotectinBeneficial
Moderate
Bifidobacterium animalis subsp. lactisReduced Faecal pHBeneficial
Moderate
Bifidobacterium animalis subsp. lactisReduced Intestinal PermeabilityBeneficial
Moderate
Bifidobacterium animalis subsp. lactis B420Absence of Adverse EventsBeneficial
Large
Bifidobacterium animalis subsp. lactis B420Increased Fecal BifidobacteriaBeneficial
Moderate
Bifidobacterium animalis subsp. lactis B420Increased Fecal Immunoglobulin A LevelsBeneficial
Moderate
Bifidobacterium animalis subsp. lactis B420Increased Short-Chain Fatty Acids ConcentrationsBeneficial
Moderate
Bifidobacterium animalis subsp. lactis B420No Change in Risk of Stage 2 or Higher Necrotizing EnterocolitisNeutral
Small
Bifidobacterium animalis subsp. lactis B420No Change in Sepsis RiskNeutral
Small
Bifidobacterium animalis subsp. lactis B420Reduced Fecal CalprotectinBeneficial
Moderate
Bifidobacterium animalis subsp. lactis B420Reduced Intestinal PermeabilityBeneficial
Moderate
Bifidobacterium animalis subsp. lactis B420Reduced Stool pHBeneficial
Moderate
Bifidobacterium animalis subsp. lactis B420Unchanged Use of AntibioticsNeutral
Small
Bifidobacterium animalis subsp. lactis BLC1Increased Fecal Bifidobacteria LevelsBeneficial
Moderate
Bifidobacterium animalis subsp. lactis BLC1Increased Fecal Immunoglobulin A ConcentrationsBeneficial
Moderate
Bifidobacterium animalis subsp. lactis BLC1Increased Short Chain Fatty AcidsBeneficial
Moderate
Bifidobacterium animalis subsp. lactis BLC1No Change in Antibiotic UsageNeutral
Small
Bifidobacterium animalis subsp. lactis BLC1No Change in Risk of Necrotizing EnterocolitisNeutral
Small
Bifidobacterium animalis subsp. lactis BLC1No Change in Sepsis RiskNeutral
Small
Bifidobacterium animalis subsp. lactis BLC1Reduced Faecal CalprotectinBeneficial
Moderate
Bifidobacterium animalis subsp. lactis BLC1Reduced Faecal pHBeneficial
Moderate
Bifidobacterium animalis subsp. lactis BLC1Reduced Intestinal PermeabilityBeneficial
Moderate
Bifidobacterium animalis subsp. lactis BS-01Increased Fecal Bifidobacteria LevelsBeneficial
Moderate
Bifidobacterium animalis subsp. lactis BS-01Increased Fecal Immunoglobulin A ConcentrationsBeneficial
Moderate
Bifidobacterium animalis subsp. lactis BS-01Increased Short Chain Fatty AcidsBeneficial
Moderate
Bifidobacterium animalis subsp. lactis BS-01No Change in Antibiotic UsageNeutral
Small
Bifidobacterium animalis subsp. lactis BS-01No Change in Risk of Necrotizing Enterocolitis Stage 2 or HigherNeutral
Small
Bifidobacterium animalis subsp. lactis BS-01No Change in Sepsis RiskNeutral
Small
Bifidobacterium animalis subsp. lactis BS-01Reduced Clostridium CountsBeneficial
Moderate
Bifidobacterium animalis subsp. lactis BS-01Reduced Enterobacteriaceae CountsBeneficial
Moderate
Bifidobacterium animalis subsp. lactis BS-01Reduced Faecal CalprotectinBeneficial
Moderate
Bifidobacterium animalis subsp. lactis BS-01Reduced Faecal pHBeneficial
Moderate
Bifidobacterium animalis subsp. lactis BS-01Reduced Intestinal PermeabilityBeneficial
Moderate
Bifidobacterium animalis subsp. lactis CECT 8145Increased Fecal Bifidobacteria LevelsBeneficial
Moderate
Bifidobacterium animalis subsp. lactis CECT 8145Increased Fecal Immunoglobulin A ConcentrationsBeneficial
Moderate
Bifidobacterium animalis subsp. lactis CECT 8145Increased Short Chain Fatty AcidsBeneficial
Moderate
Bifidobacterium animalis subsp. lactis CECT 8145No Change in Antibiotic UsageNeutral
Small
Bifidobacterium animalis subsp. lactis CECT 8145No Change in Risk of Necrotizing EnterocolitisNeutral
Small
Bifidobacterium animalis subsp. lactis CECT 8145No Change in Sepsis RiskNeutral
Small
Bifidobacterium animalis subsp. lactis CECT 8145Reduced Clostridium CountsBeneficial
Moderate
Bifidobacterium animalis subsp. lactis CECT 8145Reduced Enterobacteriaceae CountsBeneficial
Moderate
Bifidobacterium animalis subsp. lactis CECT 8145Reduced Faecal CalprotectinBeneficial
Moderate
Bifidobacterium animalis subsp. lactis CECT 8145Reduced Faecal pHBeneficial
Moderate
Bifidobacterium animalis subsp. lactis CECT 8145Reduced Intestinal PermeabilityBeneficial
Moderate
Bifidobacterium animalis subsp. lactis LAFTI B94Increased Antibiotic UseNeutral
Small
Bifidobacterium animalis subsp. lactis LAFTI B94Increased Fecal Bifidobacteria LevelsBeneficial
Moderate
Bifidobacterium animalis subsp. lactis LAFTI B94Increased Fecal Immunoglobulin A ConcentrationsBeneficial
Moderate
Bifidobacterium animalis subsp. lactis LAFTI B94Increased Risk of Necrotizing Enterocolitis Stage 2 or HigherNeutral
Small
Bifidobacterium animalis subsp. lactis LAFTI B94Increased Risk of SepsisNeutral
Small
Bifidobacterium animalis subsp. lactis LAFTI B94Increased Short Chain Fatty AcidsBeneficial
Moderate
Bifidobacterium animalis subsp. lactis LAFTI B94Reduced Faecal CalprotectinBeneficial
Moderate
Bifidobacterium animalis subsp. lactis LAFTI B94Reduced Faecal pHBeneficial
Moderate
Bifidobacterium animalis subsp. lactis LAFTI B94Reduced Intestinal PermeabilityBeneficial
Moderate
Bifidobacterium animalis subsp. lactis VK2Increased Fecal Bifidobacteria LevelsBeneficial
Moderate
Bifidobacterium animalis subsp. lactis VK2Increased Fecal Immunoglobulin A ConcentrationsBeneficial
Moderate
Bifidobacterium animalis subsp. lactis VK2Increased Short Chain Fatty AcidsBeneficial
Moderate
Bifidobacterium animalis subsp. lactis VK2No Adverse Events ObservedNeutral
Small
Bifidobacterium animalis subsp. lactis VK2No Change in Antibiotic UsageNeutral
Small
Bifidobacterium animalis subsp. lactis VK2No Change in Risk of Necrotizing Enterocolitis Stage 2 or HigherNeutral
Small
Bifidobacterium animalis subsp. lactis VK2No Change in Sepsis RiskNeutral
Small
Bifidobacterium animalis subsp. lactis VK2Reduced Faecal CalprotectinBeneficial
Moderate
Bifidobacterium animalis subsp. lactis VK2Reduced Faecal pHBeneficial
Moderate
Bifidobacterium animalis subsp. lactis VK2Reduced Intestinal PermeabilityBeneficial
Moderate
Bifidobacterium lactisIncreased Fecal Bifidobacteria LevelsBeneficial
Moderate
Bifidobacterium lactisIncreased Fecal Immunoglobulin A ConcentrationsBeneficial
Moderate
Bifidobacterium lactisIncreased Short Chain Fatty AcidsBeneficial
Moderate
Bifidobacterium lactisNo Change in Antibiotic UsageNeutral
Small
Bifidobacterium lactisNo Change in Risk of Stage 2 or Higher Necrotizing EnterocolitisNeutral
Small
Bifidobacterium lactisNo Change in Sepsis RiskNeutral
Small
Bifidobacterium lactisReduced Faecal CalprotectinBeneficial
Moderate
Bifidobacterium lactisReduced Faecal pHBeneficial
Moderate
Bifidobacterium lactisReduced Intestinal PermeabilityBeneficial
Moderate
Bifidobacterium lactis B420Increased Antibiotic UseNeutral
Small
Bifidobacterium lactis B420Increased Fecal Bifidobacteria LevelsBeneficial
Moderate
Bifidobacterium lactis B420Increased Fecal Immunoglobulin A ConcentrationsBeneficial
Moderate
Bifidobacterium lactis B420Increased Risk of Necrotizing Enterocolitis Stage 2 or HigherNeutral
Small
Bifidobacterium lactis B420Increased Risk of SepsisNeutral
Small
Bifidobacterium lactis B420Increased Short Chain Fatty AcidsBeneficial
Moderate
Bifidobacterium lactis B420Reduced Clostridium CountsBeneficial
Moderate
Bifidobacterium lactis B420Reduced Enterobacteriaceae CountsBeneficial
Moderate
Bifidobacterium lactis B420Reduced Faecal CalprotectinBeneficial
Moderate
Bifidobacterium lactis B420Reduced Faecal pHBeneficial
Moderate
Bifidobacterium lactis B420Reduced Intestinal PermeabilityBeneficial
Moderate
Bifidobacterium lactis Bl-04Adverse Events Due to SupplementationNeutral
Small
Bifidobacterium lactis Bl-04Increased Antibiotic UseNeutral
Small
Bifidobacterium lactis Bl-04Increased Fecal BifidobacteriaBeneficial
Moderate
Bifidobacterium lactis Bl-04Increased Fecal Immunoglobulin A LevelsBeneficial
Moderate
Bifidobacterium lactis Bl-04Increased Fecal Short-Chain Fatty Acid ConcentrationsBeneficial
Moderate
Bifidobacterium lactis Bl-04Increased Risk of Necrotizing Enterocolitis Stage 2 or HigherNeutral
Small
Bifidobacterium lactis Bl-04Increased Risk of SepsisNeutral
Small
Bifidobacterium lactis Bl-04Reduced Clostridium Species CountsBeneficial
Moderate
Bifidobacterium lactis Bl-04Reduced Enterobacterial CountsBeneficial
Moderate
Bifidobacterium lactis Bl-04Reduced Fecal CalprotectinBeneficial
Moderate
Bifidobacterium lactis Bl-04Reduced Intestinal PermeabilityBeneficial
Moderate
Bifidobacterium lactis Bl-04Reduced Stool pHBeneficial
Moderate
Bifidobacterium lactis BL818Increased Fecal BifidobacteriaBeneficial
Moderate
Bifidobacterium lactis BL818Increased Fecal Immunoglobulin A LevelsBeneficial
Moderate
Bifidobacterium lactis BL818Increased Short-Chain Fatty Acids ConcentrationsBeneficial
Moderate
Bifidobacterium lactis BL818No Adverse Events Associated with B Lactis SupplementationNeutral
Large
Bifidobacterium lactis BL818No Change in Antibiotic UsageNeutral
Small
Bifidobacterium lactis BL818No Change in Risk of Necrotizing Enterocolitis Stage 2 or HigherNeutral
Small
Bifidobacterium lactis BL818No Change in Sepsis RiskNeutral
Small
Bifidobacterium lactis BL818Reduced Clostridium Species CountsBeneficial
Moderate
Bifidobacterium lactis BL818Reduced Enterobacterial CountsBeneficial
Moderate
Bifidobacterium lactis BL818Reduced Fecal CalprotectinBeneficial
Moderate
Bifidobacterium lactis BL818Reduced Intestinal PermeabilityBeneficial
Moderate
Bifidobacterium lactis BL818Reduced Stool pHBeneficial
Moderate
Bifidobacterium lactis BLA80Absence of Adverse EventsBeneficial
Large
Bifidobacterium lactis BLA80Increased Fecal Bifidobacteria LevelsBeneficial
Moderate
Bifidobacterium lactis BLA80Increased Fecal Immunoglobulin A ConcentrationsBeneficial
Moderate
Bifidobacterium lactis BLA80Increased Short Chain Fatty AcidsBeneficial
Moderate
Bifidobacterium lactis BLA80No Reduced Risk of Necrotizing EnterocolitisNeutral
Small
Bifidobacterium lactis BLA80No Reduction in Antibiotic UseNeutral
Small
Bifidobacterium lactis BLA80Reduced Clostridium CountsBeneficial
Moderate
Bifidobacterium lactis BLA80Reduced Enterobacteriaceae CountsBeneficial
Moderate
Bifidobacterium lactis BLA80Reduced Faecal CalprotectinBeneficial
Moderate
Bifidobacterium lactis BLA80Reduced Faecal pHBeneficial
Moderate
Bifidobacterium lactis BLA80Reduced Intestinal PermeabilityBeneficial
Moderate
Bifidobacterium lactis BLA80Unchanged Risk of SepsisNeutral
Small
Bifidobacterium lactis MAK16B42LIncreased Fecal Bifidobacteria LevelsBeneficial
Moderate
Bifidobacterium lactis MAK16B42LIncreased Fecal Immunoglobulin A ConcentrationsBeneficial
Moderate
Bifidobacterium lactis MAK16B42LIncreased Short Chain Fatty AcidsBeneficial
Moderate
Bifidobacterium lactis MAK16B42LNo Change in Antibiotic UsageNeutral
Small
Bifidobacterium lactis MAK16B42LNo Change in Risk of Necrotizing Enterocolitis Stage 2 or HigherNeutral
Small
Bifidobacterium lactis MAK16B42LNo Change in Sepsis RiskNeutral
Small
Bifidobacterium lactis MAK16B42LReduced Faecal CalprotectinBeneficial
Moderate
Bifidobacterium lactis MAK16B42LReduced Faecal pHBeneficial
Moderate
Bifidobacterium lactis MAK16B42LReduced Intestinal PermeabilityBeneficial
Moderate

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