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Microbiome Modulator

SER-155 for Bone Marrow Transplant Complications

Phase 1

Recruiting

Led By Doris Ponce, MD

Research Sponsored by Seres Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 100

Awards & highlights

Study Summary

This trial is testing a new drug to see if it can reduce the risk of infection and graft vs. host disease in adults undergoing stem cell transplantation.

Who is the study for?

Adults over 18 planning to undergo a bone marrow transplant from various donor types, with any conditioning regimen. Not for those who've had CAR-T therapy, vancomycin allergy, certain transplants like umbilical cord blood or T-cell-depleted HSCT, active severe colitis/IBD, recent investigational treatments, hematologic malignancy relapse/progression (except minimal residual disease), or recent live microbial therapeutics.Check my eligibility

What is being tested?

The study is testing SER-155 and its placebo in adults undergoing stem cell transplantation. It's designed to see if SER-155 can reduce infection risk and graft vs. host disease compared to placebo. Participants will also receive either vancomycin pre-treatment or its placebo before the main intervention.See study design

What are the potential side effects?

While specific side effects are not listed here, potential risks may include reactions related to immune system modulation such as infections or allergic responses due to SER-155 or the vancomycin pre-treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 100

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 100

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 100 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Engraftment of SER-155

Safety and tolerability of SER-155, including incidence and severity of adverse events, serious adverse events, or adverse events of special interest

Secondary outcome measures

Abundance of Enterococcus and Enterobacteriaceae

Combined and individual incidence of bloodstream infections, gastrointestinal infections, and acute Graft-versus Host Disease

Incidence and duration of febrile neutropenia

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2 - Randomized, Double-Blind, Placebo-Controlled StudyExperimental Treatment4 Interventions

Vancomycin & SER-155 OR Vancomycin placebo & SER-155 placebo

Group II: Cohort 1 - Open Label StudyExperimental Treatment2 Interventions

Vancomycin & SER-155

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Seres Therapeutics, Inc.Lead Sponsor

8 Previous Clinical Trials

905 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterOTHER

1,936 Previous Clinical Trials

588,823 Total Patients Enrolled

Doris Ponce, MDPrincipal InvestigatorMSKCC

Media Library

SER-155 (Microbiome Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT04995653 — Phase 1

Bone Marrow Transplant Research Study Groups: Cohort 1 - Open Label Study, Cohort 2 - Randomized, Double-Blind, Placebo-Controlled Study

Bone Marrow Transplant Clinical Trial 2023: SER-155 Highlights & Side Effects. Trial Name: NCT04995653 — Phase 1

SER-155 (Microbiome Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04995653 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you elaborate on the research that has been done concerning SER-155?

"Presently, there are 55 SER-155 trials in progress. Of these studies, 6 have reached the third phase of clinical trial testing. Although a majority of these evaluations take place near Jupiter, Florida, there are 315 other locations running trials for this medication."

Answered by AI

How many research sites are conducting this experiment?

"In addition to Mayo Clinic - Scottsdale in Scottsdale, Arizona, University of Florida - Division of Hematology & Oncology in Gainesville, Washington and Fred Hutchinson Cancer Research Center in Seattle Massachusetts; 8 other clinical sites are participating this trial."

Answered by AI

What is the current size of the patient cohort for this investigation?

"To satisfactorily complete this clinical trial, a total of 75 participants must be recruited that meet the selection criteria. Patients can join the study at Mayo Clinic - Scottsdale in Scottsdale, Arizona and University of Florida - Division of Hematology & Oncology in Gainesville, Washington."

Answered by AI

Are there any available opportunities for participants in this experiment?

"Confirmed. According to clinicaltrials.gov, this medical trial has been open for recruitment since November 24th 2021 and was last updated on the 7th of November 2022 - it is still actively seeking participants."

Answered by AI

What medical conditions has SER-155 proven to be most effective in treating?

"SER-155 is a clinically approved treatment for staphylococcal infections, the various illnesses caused by staphylococci, and enterocolitis resulting from Staphylococcus aureus."

Answered by AI

Are there any documented hazards to taking SER-155?

"Due to the initial stage of clinical research, SER-155's safety rating is estimated to be 1 on a scale from 1 to 3. This is because there are limited studies confirming its efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT

2021. "A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04995653.

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