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SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)
NCT02437487 · View on ClinicalTrials.gov ↗
Study Summary
The study will involve administering the study drug as a single dose of study drug or placebo. This study is designed to demonstrate the superiority of the experimental drug versus placebo in adult patients with recurrent CDI.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SER-109
Study Locations (20)
Florida
- ZASA Clinical Research — Atlantis
- Omega Research Consultants LLC — DeBary
- Borland-Groover Clinic — Jacksonville
- Gastroenterology Group of Naples — Naples
- Advanced Medical Research Center — Port Orange
California
- North County Gastroenterology — Oceanside
- University Of California Davis — Sacramento
- Ventura Clinical Trials — Ventura
Maryland
- Anne Arundel Health System Research Institute — Annapolis
- Johns Hopkins Bayview Medical — Baltimore
- Metropolitan Gastroenterolgy Group Pc — Chevy Chase
Massachusetts
- Massachusetts General Hospital — Boston
- Beth Israel Deaconess Med Cntr — Boston
Georgia
- Emory University — Atlanta
Idaho
- Idaho Falls Infection Diseases — Idaho Falls
Louisiana
- Ochsner Clinic Foundation — New Orleans
Michigan
- William Beaumont Hospital — Royal Oak
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2015-05 |
| Est. Completion | 2016-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02437487
The ClinicalTrials.gov registry entry for NCT02437487 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seres Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Clostridium Difficile appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02437487 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02437487 about?
NCT02437487 is a clinical study titled "SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)". The study will involve administering the study drug as a single dose of study drug or placebo. This study is designed to demonstrate the superiority of the experimental drug versus placebo in adult patients with recurrent CDI.
What is the current status of trial NCT02437487?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 89 participants. The study started on 2015-05. Estimated completion is 2016-10.
What conditions does trial NCT02437487 study?
This clinical trial studies the following conditions: Clostridium Difficile. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02437487?
The interventions under investigation include: Placebo (DRUG), SER-109 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02437487?
This trial is sponsored by Seres Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02437487 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Idaho, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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