Double-blind, randomised clinical assay to evaluate the efficacy of probiotics in preterm newborns weighing less than 1500 g in the prevention of necrotising enterocolitis
- Luis Alberto Fernández-Carrocera1,2,
- Aide Solis-Herrera1,
- Marisol Cabanillas-Ayón1,
- Rocío Beatriz Gallardo-Sarmiento1,
- Carmina Sarisol García-Pérez1,
- Rosalba Montaño-Rodríguez1,
- Maria Olga Leticia Echániz-Aviles1
- 1Neonatology, Instituto Nacional de Perinatología, Distrito Federal, Mexico
- 2Subdirección Neonatología, Instituto Nacional de Perinatología, Distrito Federal, Distrito Federal, Mexico
- Correspondence to Maria Olga Leticia Echániz-Aviles, Neonatology Department, Instituto Nacional de Perinatología, Montes Urales 800 CP 11000, México;
Contributors Dr Fernández-Carrocera and Dr Echániz contributed equally in the design and analysis of the results of the study. Dr Solis-Herrera and Cabanillas-Ayon participated in the recruitment and follow-up of the patients and Dr Gallardo Sarmiento, García-Pérez and Montaño-Rodriguez worked in the data base and analysis of results.
- Received 4 June 2011
- Accepted 8 March 2012
- Published Online First 3 May 2012
Background A randomised, double-blind clinical trial was undertaken in order to assess the effectiveness of probiotics in the prevention of necrotising enterocolitis (NEC) in newborns weighing <1500 g.
Methods We studied a group of 150 patients who were randomised in two groups after parental consent was obtained, to receive either a daily feeding supplementation with a multispecies probiotic (Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus plantarum, Bifidobacteruim infantis, Streptococcus thermophillus) 1 g per day plus their regular feedings or to receive their regular feedings with nothing added (control group), over the period of January 2007 through June 2010. Clinicians in care of the infants were blinded to the group assignment.
Results The primary outcome was the development of NEC. Both groups were comparable, with no differences during hospitalisation, including the type of nutrition received. Blood cultures obtained from cases that developed sepsis did not reveal lactobacillus or Bifidobacteria growth. No differences were detected in terms of NEC risk reduction (RR: 0.54, 95% CI 0.21 to 1.39) although we did observe a clear trend in the reduction of NEC frequency in the studied cases: 6 (8%) versus 12 (16%) in the control group. When the combined risk of NEC or death was calculated as a post hoc analysis, we found a significantly lower risk (RR: 0.39, 95% CI 0.17 to 0.87) for the study group.
Conclusions Probiotics may offer potential benefits for premature infants and are a promising strategy in the reduction of the risk of NEC in preterm newborns.
Competing interests None.
Ethics approval This study was conducted with the approval of the Instituto Nacional de Perinatología Investigation Comitee with the registration number 10231.
Provenance and peer review Not commissioned; externally peer reviewed.