STP206 for the Prevention of Necrotizing Enterocolitis (NEC)
Condition: Necrotizing Enterocolitis
MeSH terms: Enterocolitis; Enterocolitis, Necrotizing
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a sequential dose escalation study to assess the safety, tolerability, and
      preliminary NEC-preventative efficacy of two doses of STP206 versus control in very low birth
      weight and extremely low birth weight neonates.
    

Detailed description: 
      Protocol STP206-002 is designed as a multi-center, randomized, double-blind, placebo
      controlled dose escalation study of the safety and tolerability of two doses of STP206 versus
      control in four sequentially decreasing birth weight strata. The primary objective of this
      study is to assess the safety and tolerability of once daily dosing of two dose levels of
      STP206 versus control in four different birth weight strata in premature neonates. Secondary
      objectives of this study include assessment of fecal shedding of STP206 throughout dosing and
      describing the incidence of NEC, incidence of relevant clinical events (sepsis/bacteremia,
      feeding intolerance, morbidity/complications of prematurity) and neonatal growth progression
      in the STP206 and control treatment groups.

      Neonates for whom informed consent is obtained and who meet eligibility criteria will be
      eligible to enroll in this study. All neonates enrolled will receive daily doses of blinded
      study treatment for between 2 and 11 weeks with the duration of dosing based upon gestational
      age at birth. All neonates enrolled in the study will be placed under Universal Precautions
      and all study personnel with subject contact are trained in appropriate neonatal intensive
      care unit (NICU) infection control practices. While in the NICU, neonates will be evaluated
      daily for signs/symptoms of NEC, feeding volumes/feeding tolerance, adverse events, and
      concomitant medications. Physical examinations and vital signs will be performed daily during
      the dosing period and at the end of dosing/NICU discharge. Growth assessments will be
      performed every other week while in the NICU and at the end of dosing/NICU discharge.
      Assessments for complications of prematurity, including retinopathy of prematurity (ROP),
      intraventricular hemorrhage (IVH), and bronchopulmonary dysplasia (BPD) will be performed at
      protocol defined timeframes. Neonates enrolled in the study will have fecal/meconium samples
      collected daily through 4 days following the start of dosing and weekly thereafter until NICU
      discharge to determine fecal shedding of STP6 and STP11. Following completion of blinded
      study treatment dosing, neonates will be evaluated at 1 week, 4 weeks, 3 months, and 6 months
      for safety and growth assessments.

      Neonates will be stratified into the following four birth weights: 2000-1501g, 1500 to 1000
      g, 999 to 750 g and 749 to 500 g. Each birth weight stratum will contain 2 dosing groups - a
      low dose STP206 group and a high dose STP206 group. Within each birth weight strata/dose
      level, subjects will be randomized in a 2:1 ratio to the STP206 or control group. Enrollment
      of neonates into study groups will occur sequentially. Enrollment into the high dose group
      within a birth weight stratum will not proceed until after the safety data from the low dose
      group is reviewed by the study independent Data Safety Monitoring Committee (DSMC).
      Similarly, enrollment into the next lower birth weight stratum will not proceed until the
      safety data from the high dose group of the prior weight stratum is reviewed by the study
      independent Data Safety Monitoring Committee (DSMC).
    

Intervention name(s): STP206; Control
Intervention type(s): Biological; Other
Intervention description(s): Live Biotherapeutic; Sterile Water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention