In April of 2016, I attended the Annual Pediatric Pharmacy Advocacy Group (PPAG) Conference in Atlanta where two Clinical Neonatal Pharmacy Specialists from the University of Illinois at Chicago College of Pharmacy presented a comprehensive review, using the most recent Probiotics for Necrotizing Enterocolitis (NEC) studies and study reviews. Click here for the public slides: PPAG Review
Their recommendations included using probiotics with both lactobacillus and bifidobacterium with at least 1 billion CFUs. When they broke down the studies, they found that the data were stronger with multi-strain probiotics vs single strain probiotics. They also recommended using powder packets vs bulk powder to prevent cross contamination in the NICU.
I later learned another PPAG clinical pharmacist, Sherry A. Luedtke from Texas Tech University Health Science Center School of Pharmacy, had participated in an earlier review article published in Journal of Pediatrics Pharmacol Therapy (JPPT) in 2012 titled “Probiotics and Nectrotizing Enterocolitis: Finding the Missing Pieces of the Probiotic Puzzle.” They too determined that single strain probiotic studies resulted in data that were not statistically significant and that products with more than one strain using L acidophilus plus Bifidobacterium showed better results. Other important considerations were products containing a prebiotic, free of food allergens, powder form that did not clog tubes and reduce cross contamination, and products not requiring refrigeration. They also expressed concern: “…most of the products evaluated in premature infants are not manufactured or marketed in the United States.”
However, one of the most important factors for Luedtke and colleagues appeared to be actual NEC rates: “NEC rate should be one of the first determinants when considering the use of probiotics for the prevention of NEC in the NICU.” This is because probiotics have shown to significantly lower NEC in NICUs with a high incidence where the positive effects of probiotics appear to decrease with lower rates of NEC. They looked to determine if there would be a significant reduction in NEC in the US with a relatively low rate of 5% to 7%.
Since there is a lack of studies conducted in the US, they looked at two studies conducted in Taiwan by Lin and colleagues†&†† (which best represented US NEC rates) evaluated VLBW infants who received breast milk and L. acidophilus and B. infantis, while the control group received only breast milk. They found the incidence of NEC was significantly lower in the probiotic group vs the control group. Lin and colleagues followed up with a larger study of 434 infants with a similar product and again it resulted in a significant decrease in NEC. Luedtke and colleagues concluded the results of the Lin studies:
“provided strong evidence suggesting potential benefit of probiotics for the prevention of NEC in the United States.”
The Cochrane Review, yet another reputable review of 24 NEC-Probiotic studies also shows a significant reduction in necrotizing enterocolitis (NEC) in preterm infants. The authors concluded:
“Enteral supplementation of probiotics prevents severe NEC and all cause mortality in preterm infants. Our updated review of available evidence strongly supports a change in practice. Head to head comparative studies are required to assess the most effective preparations, timing, and length of therapy to be utilized.”
There is growing and reputable evidence showing probiotics help prevent NEC in preterm infants, but yet only < 10% of NICUs in the US use them.
FloraTummys Probiotic powder packets meet or even exceed the criteria presented above: 5 billion CFUs of both bifidobacterium lactis and lactobacillus acidophilus, prebiotic fiber (FOS), made in the USA, powder packets easily dissolve and do not require refrigeration.
Several NICUs have started using FloraTummys to help prevent NEC, mixing one packet with 3ml of breast milk or formula during feeding.
FloraTummys is available through all drug wholesalers and in a 30ct and 10ct. For list of drug wholesalers and item numbers click here.
†Lin HC, Su BH, Chen AC. Oral probiotics reduce the incidence and severity of necrotizing enterocolitis in very low birth weight infants. Pediatrics. 2005;115(1):1–4. et al. [PubMed]
††Lin HC, Hsu CH, Chen HL. Oral probiotics prevent necrotizing enterocolitis in very low birth weight preterm infants: a multicenter, randomized, controlled trial. Pediatrics. 2008;122(4):693–700. et al. [PubMed]