The Sponsor is conducting a clinical study with STP206 for the prevention of Necrotizing Enterocolitis (NEC) in preterm infants weighing less than 4.4 lbs. (2000g). NEC is the most common serious disease of the gut in preterm infants. The purpose of this study is to look at the safety of STP206 in babies born early, and to get early information on whether STP206 may prevent NEC.
STP206 is an investigational product, meaning it is not yet approved by the US Food and Drug Administration for use in the United States. STP206 contains live bacteria and is considered a Live Biotherapeutic. The two types of bacteria are Lactobacillus and Bifidobacteria. These bacteria are used in foods such as cheese, yogurt, sauerkraut, and pickles, and have been consumed safely for years and are commonly contained in probiotic products that are currently sold throughout the world. These bacteria also are normally present in parts of the body such as bowel, mouth, skin, and the vagina. These bacteria generally do not cause disease. There have been studies of probiotic bacteria in premature babies that suggest these types of bacteria are effective in preventing NEC. The purpose of this study is to determine the safety of STP206 and if it is effective in preventing NEC.
A program has been created to provide this specialized preterm infant/mother outpatient lactation support. Titled "Promoting Lactation Education, Access and Support Efforts for Preterm Infants" (PLEASE for preterm infants), it includes (1) equipment availability and (2) pediatric clinic-based lactation counseling support. To determine the effectiveness and implementation of this program in a real-world environment requires evaluation in a racially, socioeconomically, and geographically diverse population. The eight-county coastal area of SC provides that diversity. Through the SC Pediatric Practice Research Network (SCPPRN), the effectiveness of the program will be studied through 14 pediatric care clinics