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Microbiome Modulator

A Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis

Phase 1
Waitlist Available
Research Sponsored by Seres Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Ulcerative colitis diagnosed by routine clinical, radiographic, endoscopic and pathologic criteria (preferably confirmed by colonoscopy and pathology records within last 2 years or if unavailable, will need approval by medical monitor) Active mild-moderate UC as determined by sigmoidoscopy within approximately 3 days of randomization to study
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 246
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

A Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects with Mild-to-Moderate Ulcerative Colitis.

Eligible Conditions
  • Colitis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 246
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 246 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composition of the Intestinal Microbiome
Engraftment of SER-287 Bacteria in All Treatment Arms
Safety and Tolerability of SER-287
Secondary study objectives
Clinical Remission
Endoscopic Improvement

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Weekly SER-287, after Vanco. Pre-Treat.Experimental Treatment2 Interventions
Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Group II: Weekly SER-287, after Placebo Pre-Treat.Experimental Treatment2 Interventions
Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Group III: Daily SER-287, after Vanco. Pre-Treat.Experimental Treatment2 Interventions
Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks
Group IV: Daily placebo, after Placebo Pre-Treat.Placebo Group2 Interventions
Placebo pre-treatment, followed by once daily placebo for 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vancomycin
FDA approved
SER-287
2016
Completed Phase 1
~60
Placebo Pre-Treat
2016
Completed Phase 1
~60

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Who is running the clinical trial?

Seres Therapeutics, Inc.Lead Sponsor
8 Previous Clinical Trials
907 Total Patients Enrolled
1 Trials studying Colitis
203 Patients Enrolled for Colitis
~6 spots leftby Jan 2026
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