NCT04995653 - SER-155 & Allogeneic hematopoietic stem cell transplantation (allo HSCT)

Study overview

It is an open-label and randomized, double-blind, placebo-controlled clinical phase I trial studying SER-155 in 34 randomized male and female subjects ≥ 18 years of age undergoing Allogeneic hematopoietic stem cell transplantation (allo HSCT) after microbiome conditioning with oral vancomycin

Primary outcome measures

Safety, engraftment of SER-155

Results

• Bloodstream Infections (BSI) occurrence:
  
  
  • SER-155 group: 2 participants (10%),
  
  
  • Placebo group: 6 participants (43%)
  
  
  
  


• BSI pathogens were typical for post-allo-HCT; no SER-155 species found in BSI.


• All BSI occurred between HCT Days 4 and 15, before neutrophil recovery.


• All BSI were treated …