ECOSPOR IV: An Open-Label Extension of Study SERES-012 and Open-Label Program for Evaluating SER-109 in Adult Subjects with Recurrent Clostridioides difficile Infection (RCDI)

  • STATUS
    Recruiting
Updated on 21 December 2020
Investigator
Michele Trucksis, PhD, MD
Primary Contact
University Gastroenterology (2.5 mi away) Contact
+76 other location
clostridium difficile

Summary

ECOSPOR IV is a Phase 3, multicenter, Open Label study to evaluate the safety and tolerability of SER-109 in adult subjects with recurrent CDI.

Description

Approximately 195 subjects with at least two episodes of CDI (including current episode) in the previous 12 months from Screening, a positive C. difficile toxin test result on a stool sample, and who have responded to standard-of-care (SOC) antibiotic treatment will be enrolled. 

All enrolled subjects will have access to our Investigational Product, SER-109.

Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days.

SERES-013 Cohort 2 is a 24-week study, comprised of three study periods (Screening, Treatment, and Safety Follow Up), with two clinic visits and all other visits can be telephone visits.

Details
Condition Clostridium Difficile-Associated Diarrhea
Clinical Study IdentifierTX255303
Last Modified on21 December 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Have a documented history of at least 2 episodes of CDI (including a current episode) in the last 12 months
If currently taking probiotics, must be willing to stop at time of consent, for the duration of the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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