5-10% of the smallest premature infants develop necrotizing enterocolitis (NEC), a potentially lethal disorder in which portions of the bowel undergo tissue death. A key goal in the treatment of preterm infants is achievement of full enteral feeding as early as possible to optimize growth (and to improve longer term clinical outcomes.

To ensure adequate production quality and to assess the risks and benefits of medicines that treat a disease, drugs must be approved by a regulatory medicines agency before use. This review is particularly important given the vulnerability of the preterm babies. To date no dietary/probiotic product on the market has been approved by these regulatory agencies. IBT is committed to develop the first pharmaceutical grade live bacterial therapy by following the agency requirements.

The Connection study is the first ever regulatory medicines agency approved phase 3 study on the potential benefits of any pharmaceutical grade live bacterial therapy in premature infants.