aIn clinical studies, participants with impaired kidney function received polyethylene glycol electrolyte solution (250 mL GoLYTELY, not approved for this use).1
References: 1. VOWST [Prescribing Information]. Bridgewater, NJ: Aimmune Therapeutics, Inc. 02/2025. 2. Feuerstadt P, Louie TJ, Lashner B, et al. SER-109, an oral microbiome therapy for recurrent Clostridioides difficile infection. N Engl J Med. 2022;386(3):220-229. doi:10.1056/NEJMoa2106516
INDICATION
VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).
Limitation of Use: VOWST is not indicated for treatment of CDI.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Transmissible infectious agents: Because VOWST is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents. Report any infection that is suspected to have been transmitted by VOWST to Aimmune Therapeutics, Inc. at 1-833-246-2566.
Potential presence of food allergens: VOWST may contain food allergens. The potential to cause adverse reactions due to food allergens is unknown.
ADVERSE REACTIONS
The most common adverse reactions (reported in ≥5% of Vowst-treated participants, and at a rate greater than placebo) were abdominal distension (31.1%), fatigue (22.2%), constipation (14.4%), chills (11.1%), and diarrhea (10.0%).
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Testing the category description for testing purposes
Multicenter, randomized, double-blind, placebo-controlled,
parallel-group trial in adults (≥18 years) with recurrent
C. diff1-3
Primary Endpoint
Recurrence at 8 weeks*
Secondary Endpoints
Adverse events within 24 weeks
Recurrence at 4, 12, 24 weeks*
Recurrence confirmed with C. diff toxin test and ≥3 unformed bowel movements per day over 2 days*
10–21 days of vancomycin (125 mg QID) or fidaxomicin (200 mg BID)
ECOSPOR III efficacy endpoints based on intent-to-treat population.
Data were rounded to the nearest whole number for presentation.
STUDY DESIGN
ECOSPOR IV was an open-label, single arm study
of 263 participants with ≥1
C. diff
recurrences
evaluating the safety of VOWST;
the secondary endpoint was efficacy5
Limitations: open-label study design yields descriptive results limiting interpretations of efficacy and safety without a comparator
ECOSPOR IV
Multicenter, open-label, single-arm trial
in adults (≥18 years) with recurrent
C. diff5
Primary Endpoint
Adverse events within 24 weeks
Secondary Endpoints
Recurrence at 4, 8, 12, 24 weeks
Recurrence confirmed with
C. diff
toxin test
or
PCR
and ≥3 unformed bowel movements per day over 2 days*
10–42 days of vancomycin
or 10–25 days of fidaxomicin
Toxin and PCR testing were utilized to determine initial eligibility. Recurrences while on study were confirmed by toxin testing to ensure study integrity.
†25 placebo recipients and 4 VOWST recipients discontinued ECOSPOR III and enrolled in ECOSPOR IV after experiencing a C. Diff recurrence within 8 weeks.
Data were rounded to the nearest whole number for presentation.
