In many situations, the advice is to wait one more day and then decide/act; however, sometimes one more day winds up being a week, a month, or longer. A recent editorial indicates that there is enough evidence now for probiotic usage in neonates to prevent necrotizing enterocolitis (NEC). The authors state that to continue “with the standard of care, in which no new products are provided…is ethically unacceptable” (JAMA Pediatrics 2013; 167: 885-6). Thanks to Ben Gold for this reference.
- A 2011 Cochrane review identified 16 eligible trials with 2842 premature infants (<2500 g, <37 weeks). Probiotics reduced the incidence of NEC with a relative risk of 0.35 and mortality with a relative risk of 0.40. Despite the typically cautious recommendations from Cochrane reviews, the authors state “updated review of available evidence supports a change in practice.”
- While the American Academy of Pediatrics in 2010 noted there is some evidence to support probiotic usage and called for more studies, there are no studies currently being conducted in the U.S.
- The authors note that the “FDA Center for Biologic Evaluation and Research is committed to policies that effectively prohibit probiotic efficacy trials.” Under current policies, the authors state these “studies will not be conducted in a US setting for the next 20 to 30 years.”
- Other countries , like Australia, allow use of probiotic with parental consent.
- The authors propose that probiotic efficacy be studied in a comparative effectiveness design.
Bottomline: Current regulations have stymied the use of probiotic trials for NEC. What will it take for regulatory agencies to relent and allow this promising research?
Related blog posts:
- Potential and pitfalls of probiotics with necrotizing … – gutsandgrowth
- How helpful are probiotics? | gutsandgrowth
Disclaimer: These blog posts are for educational purposes only. Specific dosing of medications (along with potential adverse effects) and specific medical management interventions should be confirmed by prescribing physician. Application of the information in a particular situation remains the professional responsibility of the practitioner.