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ECOSPOR IV


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
617-636-3665
More Information https://www.clinicaltrials.gov/ct2/show/NCT03183141

Overview

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