NCT02437500

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

• Status: Approved For Marketing
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Seres Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

SERES-016 is a multicenter, expanded-access program (EAP) of SER-109 for subjects with RCDI conducted in the US. Up to approximately 90 subjects are expected to be treated with SER-109, or until SER-109 investigational product is exhausted. Within 3 days after end of antibiotics and on the day preceding SER-109, a bowel cleanse should be administered. Subjects who meet all the inclusion criteria and none of the exclusion criteria are eligible for participation in the EAP. Each subject (or subject's legally authorized representative) will have to sign an informed consent form (ICF) indicating their consent to participate in the EAP. Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days.

Conditions

• Clostridioides Difficile Infection

Interventions

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

Timeline

• First posted: 2015-05-07
• Last updated: 2023-06-13