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Title ECOSPOR IV: An Open-Label Extension of Study SERES-012 Evaluating SER-109 in Adult Subjects with Recurrent Clostridium difficile Infection (RCDI) 
Therapeutic Area Clostridium Difficile Infection
Principal Investigator Dr. Yoav Golan
Min Age 18 Years
Gender All
Contact Deirdre Burke
More Information


ECOSPOR IV is an open-label extension of Study SERES-012. This study is designed to evaluate the safety, tolerability, and efficacy of a SER-109 treatment regimen in adult subjects 18 years of age or older with recurrent Clostridium difficile infection (RCDI), who received a SER-109 or placebo treatment regimen in Study SERES-012. 

Study Details

Inclusion Criteria

  • Previously enrolled in SERES-012 and experienced CDI recurrence within 8 weeks after receipt of a treatment regimen
  • Positive c. difficile stool toxin assay with 3 or more unformed stools per day for 2 consecutive days
  • 3 or more episodes of CDI within the past 12 months 

Exclusion Criteria

  • Females who are pregnant or breastfeeding
  • Suspected toxic megacolon
  • History of inflammatory bowel disease causing diarrhea

Study Requirements

5 stool collections, vital signs, study drug, keeping patient diaries