Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03183128 · ClinicalTrials.gov registry record · Phase 3

ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection

A Phase 3 study, sponsored by Seres Therapeutics.

Completed
Registry status
Phase 3
Development phase
182
Enrollment target

NCT03183128 is a Phase 3 study that has completed, run by Seres Therapeutics. The registered enrollment target is 182 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03183128, a Phase 3 study, has completed, sponsored by Seres Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
182 participants
Enrollment target

Study Summary

Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in Treatment Group I or matching placebo once daily for 3 consecutive days in Treatment Group II. The purpose of this study is to demonstrate the superiority of SER-109 vs placebo to reduce recurrence of CDI as determined by a toxin assay in adults up to 8 weeks after initiation of treatment.

Interventions

  • DRUG Placebo
  • BIOLOGICAL SER-109

Trial Details

FieldValue
Enrollment Target 182 participants
Start Date 2017-07-10
Est. Completion 2020-09-29
Phase Phase 3

Sponsor

Seres Therapeutics

7 total trials

What the Registry Record Tells You About NCT03183128

The ClinicalTrials.gov registry entry for NCT03183128 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 182 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seres Therapeutics, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03183128 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03183128 about?

NCT03183128 is a clinical study titled "ECOSPOR III - SER-109 Versus Placebo in the Treatment of Adults With Recurrent Clostridium Difficile Infection". Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in Treatment Group I or matching placebo once daily for 3 consecutive days in Treatment Group II. The purpose of this study is to demonstrate the superiority of SER-109 vs placebo to reduce recurrence of CD...

What is the current status of trial NCT03183128?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 182 participants. The study started on 2017-07-10. Estimated completion is 2020-09-29.

What interventions are being tested in trial NCT03183128?

The interventions under investigation include: Placebo (DRUG), SER-109 (BIOLOGICAL).

Who is sponsoring clinical trial NCT03183128?

This trial is sponsored by Seres Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.