ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection
Public ClinicalTrials.gov record NCT03183141. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
ECOSPOR IV: An Open-Label Extension of Study SERES-012 and Open-Label Program for Evaluating SER-109 in Subjects With Recurrent Clostridioides Difficile Infection (RCDI)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Cohort 1: Subjects who had a Clostridioides difficile infection (CDI) recurrence in study SERES-012 within 8 weeks of receipt of study drug will be eligible. The purpose of this cohort is to assess safety and efficacy of SER-109 in reducing recurrence of CDI in adults who had a CDI recurrence within 8 weeks after receipt of SER-109 or Placebo in study SERES-012. Cohort 2: Cohort 2 is an open-label program for subjects who were not part of SERES-012. The purpose of this cohort is to describe safety and tolerability of SER-109 in subjects 18 years of age or older with at least a first recurrence of CDI.
Study identification
- NCT ID
- NCT03183141
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 263 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 22, 2017
- Primary completion
- Apr 28, 2022
- Completion
- Apr 28, 2022
- Last update posted
- Apr 9, 2023
2017 – 2022
United States locations
- U.S. sites
- 97
- U.S. states
- 28
- U.S. cities
- 87
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| (Investigator site) | Dothan | Alabama | 36305 | — |
| (Investigator site) | Sun City West | Arizona | 85375 | — |
| (Investigator site) | Mather | California | 95655 | — |
| (Investigator site) | Mountain View | California | 94040 | — |
| (Investigator site) | Murrieta | California | 92563 | — |
| (Investigator site) | Northridge | California | 91324 | — |
| (Investigator site) | Sacramento | California | 95817 | — |
| (Investigator site) | San Bernardino | California | 92408 | — |
| (Investigator site) | San Diego | California | 92123 | — |
| (Investigator site) | San Dimas | California | 91773 | — |
| (Investigator site) | Simi Valley | California | 93065 | — |
| (Investigator site) | Thousand Oaks | California | 91360 | — |
| (Investigator site) | Clearwater | Florida | 33756 | — |
| (Investigator site) | Clearwater | Florida | 33761 | — |
| (Investigator site) | DeLand | Florida | 32720 | — |
| (Investigator site) | Hialeah | Florida | 33016 | — |
| (Investigator site) | Homestead | Florida | 33032 | — |
| (Investigator site) | Jacksonville | Florida | 32256 | — |
| (Investigator site) | Miami | Florida | 33125 | — |
| (Investigator site) | Miami | Florida | 33126 | — |
| (Investigator site) | Miami | Florida | 33144 | — |
| (Investigator site) | Miami | Florida | 33155 | — |
| (Investigator site) | Miami | Florida | 33165 | — |
| (Investigator site) | Miami | Florida | 33175 | — |
| (Investigator site) | Miami Lakes | Florida | 33014 | — |
| (Investigator site) | Naples | Florida | 34102 | — |
| (Investigator site) | Orlando | Florida | 32819 | — |
| (Investigator site) | Pembroke Pines | Florida | 33024 | — |
| (Investigator site) | Pembroke Pines | Florida | 33026 | — |
| (Investigator site) | Port Orange | Florida | 32127 | — |
| (Investigator site) | Athens | Georgia | 30607 | — |
| (Investigator site) | Atlanta | Georgia | 30322 | — |
| (Investigator site) | Decatur | Georgia | 30033 | — |
| (Investigator site) | Marietta | Georgia | 30060 | — |
| (Investigator site) | Morrow | Georgia | 30260 | — |
| (Investigator site) | Boise | Idaho | 83706 | — |
| (Investigator site) | Idaho Falls | Idaho | 83404 | — |
| (Investigator site) | Chicago | Illinois | 60637 | — |
| (Investigator site) | Oak Lawn | Illinois | 60453 | — |
| (Investigator site) | Springfield | Illinois | 62703 | — |
| (Investigator site) | Evansville | Indiana | 47714 | — |
| (Investigator site) | Iowa City | Iowa | 52242 | — |
| (Investigator site) | Kansas City | Kansas | 66160 | — |
| (Investigator site) | New Orleans | Louisiana | 70121 | — |
| (Investigator site) | Annapolis | Maryland | 21401 | — |
| (Investigator site) | Chevy Chase | Maryland | 20815 | — |
| (Investigator site) | Glen Burnie | Maryland | 21061 | — |
| (Investigator site) | Boston | Massachusetts | 02114 | — |
| (Investigator site) | Framingham | Massachusetts | 01702 | — |
| (Investigator site) | North Dartmouth | Massachusetts | 02747 | — |
| (Investigator site) | Weymouth | Massachusetts | 02190 | — |
| (Investigator site) | Worcester | Massachusetts | 01655 | — |
| (Investigator site) | Chesterfield | Michigan | 48047 | — |
| (Investigator site) | Detroit | Michigan | 48202 | — |
| (Investigator site) | Flint | Michigan | 48504 | — |
| (Investigator site) | Royal Oak | Michigan | 48073 | — |
| (Investigator site) | Wyoming | Michigan | 49519 | — |
| (Investigator site) | Rochester | Minnesota | 55905 | — |
| (Investigator site) | Chesterfield | Missouri | 63017 | — |
| (Investigator site) | Butte | Montana | 59701 | — |
| (Investigator site) | Morristown | New Jersey | 07960 | — |
| (Investigator site) | Neptune City | New Jersey | 07754 | — |
| (Investigator site) | Buffalo | New York | 14215 | — |
| (Investigator site) | New York | New York | 10279 | — |
| (Investigator site) | Charlotte | North Carolina | 28210 | — |
| (Investigator site) | Greenville | North Carolina | 27834 | — |
| (Investigator site) | Jacksonville | North Carolina | 28546 | — |
| (Investigator site) | Kinston | North Carolina | 28501 | — |
| (Investigator site) | Akron | Ohio | 44304 | — |
| (Investigator site) | Centerville | Ohio | 45459 | — |
| (Investigator site) | Cincinnati | Ohio | 45219 | — |
| (Investigator site) | Cleveland | Ohio | 44195 | — |
| (Investigator site) | Mentor | Ohio | 44060 | — |
| (Investigator site) | Toledo | Ohio | 43617 | — |
| (Investigator site) | Camp Hill | Pennsylvania | 17011 | — |
| (Investigator site) | Harrisburg | Pennsylvania | 17110 | — |
| (Investigator site) | Pittsburgh | Pennsylvania | 15213 | — |
| (Investigator site) | Sayre | Pennsylvania | 18840 | — |
| (Investigator site) | Providence | Rhode Island | 02905 | — |
| (Investigator site) | Union City | Tennessee | 38261 | — |
| (Investigator site) | Cypress | Texas | 77429 | — |
| (Investigator site) | Garland | Texas | 75044 | — |
| (Investigator site) | Houston | Texas | 77024 | — |
| (Investigator site) | Houston | Texas | 77025 | — |
| (Investigator site) | Houston | Texas | 77057 | — |
| (Investigator site) | Houston | Texas | 77084 | — |
| (Investigator site) | McKinney | Texas | 75071 | — |
| (Investigator site) | Pasadena | Texas | 77505 | — |
| (Investigator site) | San Antonio | Texas | 78229 | — |
| (Investigator site) | Southlake | Texas | 76092 | — |
| (Investigator site) | Spring | Texas | 77379 | — |
| (Investigator site) | Ogden | Utah | 84403 | — |
| (Investigator site) | Riverton | Utah | 84065 | — |
| (Investigator site) | Salt Lake City | Utah | 84114 | — |
| (Investigator site) | Spokane | Washington | 99202 | — |
| (Investigator site) | Tacoma | Washington | 98405 | — |
| (Investigator site) | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03183141, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 9, 2023 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03183141 live on ClinicalTrials.gov.