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Microbiome Therapy
Microbiome Therapy for Antibiotic-Resistant Bacterial Colonization (FAIR Trial)
Phase 2
Recruiting
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, day 7, day 14 of last cycle (each cycle is 14 days), and 28 weeks
Awards & highlights
FAIR Trial Summary
This trial will test if MT can reduce intestinal MDRO colonization in hospitalized patients, and if it reduces transmission of MDROs to other patients in the hospital.
Who is the study for?
This trial is for adults over 18 who are colonized with certain drug-resistant bacteria but not currently ill from them. They must stop taking antibiotics, probiotics, and PPIs before the study starts and agree to use birth control. People can't join if they're very sick (like heart failure), pregnant, on strong immune system drugs, have a short life expectancy, or have other serious health issues.Check my eligibility
What is being tested?
The trial tests microbiome therapy (MT) against a placebo to see if it reduces gut colonization by multi-drug resistant organisms in hospitalized patients. This could prevent infections and reduce the need for powerful antibiotics that can harm kidneys.See study design
What are the potential side effects?
Potential side effects of MT aren't fully known but may include digestive discomfort or changes in bowel habits since it involves altering the gut's bacterial makeup.
FAIR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0, day 7, day 14 of last cycle (each cycle is 14 days), and 28 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0, day 7, day 14 of last cycle (each cycle is 14 days), and 28 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in proportion of MDRO colonized participants after last treatment cycle with the investigational product (IP)
Change in stool MDRO colony-forming unit (CFU) density
Secondary outcome measures
Estimate efficacy of the IP for reducing recurrent MDRO infection
Estimate safety of the IP for MDRO colonization after infection
Severity of adverse events caused by administration of the investigational product
+1 moreFAIR Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: microbiome therapeuticExperimental Treatment1 Intervention
The study intervention is manufactured from a healthy screened donor as an investigational product (IP) and delivered via swallowed capsule after room reset of the patient's hospital room.
Group II: PlaceboPlacebo Group1 Intervention
The control arm will remain in routine contact precautions per standard of care, take placebo capsules, and have a room reset.
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Who is running the clinical trial?
Centers for Disease Control and PreventionFED
875 Previous Clinical Trials
22,477,362 Total Patients Enrolled
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,617 Total Patients Enrolled
Michael Woodworth, MD, MScPrincipal InvestigatorEmory University
1 Previous Clinical Trials
10 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been part of a study involving new treatments or devices in the last 28 days.My immune system is weak due to conditions like AIDS, low white blood cell counts, recent intense cancer treatment, or a bone marrow transplant within the last year.I am a man and will use birth control if my partner can have children.I can follow the study rules and can swallow pills.I am willing to stop taking antibiotics, probiotics, other gut health treatments, and acid reducers before the study starts.I agree to use effective birth control or practice abstinence during the study.I am not on antibiotics, except for a recent MDRO infection treatment which I will finish before the study starts.I have serious health issues like heart problems, untreated cancer, or recent infections.I am 18 years old or older.I carry a drug-resistant bacteria as confirmed by a lab test.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: microbiome therapeutic
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there currently an opportunity for individuals to join this research study?
"Data hosted on clinicaltrials.gov suggests that this research venture is not actively recruiting patients as of now, having been initially posted in May 1st 2023 and last updated on April 18th 2023. However, there are other studies which are welcoming applicants at the present moment."
Answered by AI
Has the Food and Drug Administration certified any microbiome treatments as safe for use?
"The safety of microbiome therapy was estimated to be a 2, as Phase 2 trials have provided some evidence to suggest the treatment is safe but no efficacy data has been collected yet."
Answered by AI
How does this clinical trial hope to achieve its objectives?
"This trial seeks to measure the Change in MDRO Colony-Forming Unit (CFU) Densities over Day 0, day 14, and 24 weeks. Secondary objectives include gauging Severity of Adverse Events caused by the investigational product from time of administration until 24 weeks, Estimating efficacy for reducing recurrent MDRO Infections, and calculating Time to Recurrent MDRO Infection after Investigational Product Administration up until last final safety visit or death."
Answered by AI
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