ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection
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ClinicalTrials.gov Identifier: NCT03183141 |
Recruitment Status :
Completed
First Posted : June 9, 2017
Results First Posted : March 31, 2023
Last Update Posted : April 10, 2023
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Sponsor:
Seres Therapeutics, Inc.
Information provided by (Responsible Party):
Seres Therapeutics, Inc.
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Clostridioides Difficile Infection |
Intervention |
Biological: SER-109 |
Enrollment | 263 |
Participant Flow
Recruitment Details | Overall, there were 64 sites in the United States and 8 sites in Canada that enrolled participants between 2017 to 2021. |
Pre-assignment Details |
Arm/Group Title | Cohort 1 | Cohort 2 |
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Rollover participants from study SERES-012, who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in SERES-013 study. | Newly enrolled participants who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days. |
Period Title: Overall Study | ||
Started | 29 | 234 |
Completed 8-week Follow-up | 29 | 228 |
Completed [1] | 27 | 222 |
Not Completed | 2 | 12 |
Reason Not Completed | ||
Withdrawal by Subject | 2 | 4 |
Death | 0 | 8 |
[1]
Completed 24-week Follow-up
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Baseline Characteristics
Arm/Group Title | Cohort 1 | Cohort 2 | Total | |
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Rollover participants from study SERES-012, who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in SERES-013 study. | Newly enrolled participants who received oral dose of SER-109 in 4 capsules once daily for 3 consecutive days. | Total of all reporting groups | |
Overall Number of Baseline Participants | 29 | 234 | 263 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 29 participants | 234 participants | 263 participants | |
71.7 (12.46) | 63.1 (15.79) | 64.0 (15.67) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 29 participants | 234 participants | 263 participants | |
Female |
18 62.1%
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162 69.2%
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180 68.4%
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Male |
11 37.9%
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72 30.8%
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83 31.6%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 29 participants | 234 participants | 263 participants |
White |
29 100.0%
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214 91.5%
|
243 92.4%
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Black or African American |
0 0.0%
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14 6.0%
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14 5.3%
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Asian |
0 0.0%
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5 2.1%
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5 1.9%
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American Indian or Alaska Native |
0 0.0%
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1 0.4%
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1 0.4%
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Not Hispanic or Latino |
29 100.0%
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214 91.5%
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243 92.4%
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Hispanic or Latino |
0 0.0%
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20 8.5%
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20 7.6%
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Antibiotic regimen for qualifying episode
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 29 participants | 234 participants | 263 participants | |
Vancomycin |
22 75.9%
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169 72.2%
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191 72.6%
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Fidaxomicin |
7 24.1%
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65 27.8%
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72 27.4%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Lisa von Moltke, MD, Chief Medical Officer |
Organization: | Seres Therapeutics |
Phone: | 617-945-9626 |
EMail: | clinicalstudies@serestherapeutics.com |
Responsible Party: | Seres Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT03183141 |
Other Study ID Numbers: |
SERES-013 |
First Submitted: | June 8, 2017 |
First Posted: | June 9, 2017 |
Results First Submitted: | March 7, 2023 |
Results First Posted: | March 31, 2023 |
Last Update Posted: | April 10, 2023 |