Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03183141 · ClinicalTrials.gov registry record · Phase 3
ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection
A Phase 3 study, sponsored by Seres Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 263
- Enrollment target
NCT03183141: Completed Phase 3 study, sponsored by Seres Therapeutics.
NCT03183141 is a Phase 3 study that has completed, run by Seres Therapeutics. The registered enrollment target is 263 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03183141, a Phase 3 study, has completed, sponsored by Seres Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 263 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Cohort 1: Recurrence of CDI up to 8 Weeks after treatment. Recurrence was determined by stool Clostridioides difficile toxin assay. Sustained clinical response was the absence of CDI recurrence up to 8 Weeks after treatment.
Interventions
- BIOLOGICAL SER-109
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 263 participants |
| Start Date | 2017-10-23 |
| Est. Completion | 2022-04-29 |
| Phase | Phase 3 |
What the finished NCT03183141 record still lists
NCT03183141 is an interventional study that assigns participants to a tested intervention. The registered 263 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 1 intervention - of which SER-109 is the first listed.
NCT03183141 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03183141 about?
NCT03183141 is a clinical study titled "ECOSPOR IV: An Open-Label Study Evaluating SER-109 in Recurrent Clostridioides Difficile Infection". 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...
What is the current status of trial NCT03183141?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 263 participants. The study started on 2017-10-23. Estimated completion is 2022-04-29.
What interventions are being tested in trial NCT03183141?
The interventions under investigation include: SER-109 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03183141?
This trial is sponsored by Seres Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03183141's enrollment target sits among peer trials
263 1228th of 2000 higher than 773 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04067336 · 263 participants · Phase 1
First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia
- NCT06234423 · 263 participants · Phase 1
A Study of CUSP06 in Patients With Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors
- NCT06724627 · 263 participants · NA
Application of the Belle.AI Dermatological Image Reference System for Patient Diagnosis in an Active Clinical Setting
- NCT04101669 · 264 participants · NA
RESET System Pivotal Trial (Rev F)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI