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Expanded Access Program of SER-109 in the Treatment of Adults With Recurrent Clostridioides Difficile Infection (RCDI)

NCT02437500 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2023-06-13

No results posted yet for this study

Summary

Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days. The purpose of this study is to provide access to SER-109 for adult subjects with recurrent Clostridioides Difficile Infection (RCDI) and to monitor subject safety and report to regulatory authorities, as appropriate.

Conditions

  • Clostridioides Difficile Infection

Interventions

BIOLOGICAL

SER-109

SER-109 is an ecology of bacteria in spore form, enriched from stool donations obtained from healthy, screened donors

Sponsors & Collaborators

  • Seres Therapeutics, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02437500 on ClinicalTrials.gov