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Randomized, Controlled, Phase 1-2 Open Label Study of ST266 IV Administration to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC)
The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL/kg and 1.0 mL/kg) of once daily (QD) via IV route of…
A Single-Arm, Open-Label, Phase 1 Study to Assess Safety and Preliminary Efficacy of Cultivated Multi-Strain Live Bacterial Therapeutic SER-155 for First-Line Treatment of Immunotherapy-Related Enterocolitis
The purpose of this study is to find out whether SER-155 may be a safe first treatment that causes few or mild side effects for people due to irEC.
NETs: Protection or Harm in Neonatal Inflammation or Infection
This is a prospective in vitro cell biology study of polymorphonuclear leukocyte (PMN) protein synthesis in response to PAF. PMNs from cord blood of premature …
Study of Normal Intestinal Development and Disease in Premature and Term Neonates - a Pathway for the Study of Premature and Neonatal Intestinal Disorders Including the Roles of Nutrition, Microbes, and Cellular Physiology, and Diseases Including Necrotizing Enterocolitis
Current research on early intestinal development is primarily performed in mouse models. While useful in many other ways, mouse models are not ideal for studyi…
Clinical Model for Early Predictors of Necrotizing Enterocolitis in Neonates
The goal of this project is to identify neonates who are predisposed to Necrotizing Enterocolitis (NEC). the investigators will determine the effectiveness of …
Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome
This is a phase I multicenter clinical trial that aims to find the optimal dose for conducting a novel low-dose, multi-day oral food challenge (OFC) protocol f…