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Microbiome Therapy

Live microbiome therapeutic for Organism

Phase 1

Waitlist Available

Led By Michael Woodworth, MD, MSc

Research Sponsored by Emory University

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 0 up to 196 days

Awards & highlights

Study Summary

This trial will test the safety and efficacy of MT (AMG) to reduce MDRO colonization in patients admitted to LTACHs. #MDRO #MT #LTACH

Who is the study for?

This trial is for adults in long-term care who have drug-resistant organism colonization. They must stop certain medications, agree to contraception if applicable, and be willing to follow the study rules. People can't join if they're pregnant, need proton-pump inhibitors or antibiotics during the study, have severe illnesses that could interfere with participation, a history of serious food allergies, compromised immune systems, very short life expectancy or are in another MDROs study.Check my eligibility

What is being tested?

The trial tests Allogeneic Microbiota in Glycerol (AMG) as a treatment for patients colonized by multidrug resistant organisms. It aims to see how safe it is and how well it works when given through feeding tubes or as an enema. The goal is also to inform future larger studies on microbiome therapies' effectiveness against these drug-resistant infections.See study design

What are the potential side effects?

While AMG has shown an acceptable safety profile in smaller studies with about 60-90% efficacy for decolonization, potential side effects may include digestive disturbances due to changes in gut flora and possible allergic reactions related to ingredients within the formulation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 up to 196 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 up to 196 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 up to 196 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Frequency of adverse events by MT administration in a population with a high burden of comorbidities

Severity of adverse events caused by administration for MT in a population with a high burden of comorbidities

Secondary outcome measures

MT MDRO decolonization efficacy

Side effects data

From 2015 Phase 4 trial • 80 Patients • NCT02117687

Eye Irritation

Eye Pruritus

100%

80%

60%

40%

20%

Study treatment Arm

OPTIVE FUSION™

VISMED® Multi

Trial Design

1Treatment groups

Experimental Treatment

Group I: Live microbiome therapeuticExperimental Treatment1 Intervention

Live microbiome therapeutic prepared as Allogeneic Microbiota in Glycerol (10%) (AMG)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Allogeneic Microbiota in Glycerol (10%) (AMG)

2023

Completed Phase 1

~10

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,636 Previous Clinical Trials

2,560,563 Total Patients Enrolled

Centers for Disease Control and PreventionFED

875 Previous Clinical Trials

22,477,392 Total Patients Enrolled

Michael Woodworth, MD, MScPrincipal InvestigatorEmory University

1 Previous Clinical Trials

40 Total Patients Enrolled

Frequently Asked Questions

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

Has the FDA sanctioned Live microbiome as a treatment option?

"The safety of the live microbiome therapeutic was rated a 1 on Power's scale, as Phase 1 trials offer only preliminary evidence for both its efficacy and security."

Answered by AI

Is this research project currently recruiting participants?

"According to clinicaltrials.gov, this particular research project is no longer recruiting patients as the last update was done on March 20th of this year. However, there are still other trials in progress that could benefit from additional participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sentinel Cohort REACT

Michael Woodworth 2023. "Sentinel Cohort REACT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05780801.