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Antibiotic

Penn Microbiome Therapy - 002 for Clostridium Difficile Infection

Phase 2
Waitlist Available
Led By Ebbing Lautenbach, MD, MPH, MSCE
Research Sponsored by University of Pennsylvania
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 60 days
Awards & highlights

Study Summary

This study is evaluating whether fecal microbiota transplantation may help treat severe Clostridium difficile infection.

Eligible Conditions
  • Clostridium Difficile Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 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
Number of Subjects With Resolution of Symptoms After Treatment With One of the PMT Suite of Products.
Secondary outcome measures
All-cause Mortality at 30 Days Following Last Fecal Microbiota Transplantation (FMT)
All-cause Mortality at 60-days Following Last FMT
Bacteremia From Enrollment Until 30 Days After Last FMT
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Upper gastrointestinal Fecal Microbiota TransplantationExperimental Treatment3 Interventions
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given by mouth in capsules or through a tube that goes into your stomach/intestines if you already have one (upper delivery). You will not be assigned to this group if you cannot take any medications either by mouth or through a tube safely, as determined by your doctor
Group II: Lower gastrointestinal Fecal Microbiota TransplantationExperimental Treatment2 Interventions
Participants who receive the antibiotics usually prescribed for C diff infection, along with PMT that is given through the rectum by an enema (lower delivery).
Group III: No investigational productActive Control1 Intervention
Participants who receive the antibiotics usually prescribed for C diff infection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Antibiotics
2017
Completed Phase 4
~5180

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,998 Previous Clinical Trials
42,879,367 Total Patients Enrolled
Ebbing Lautenbach, MD, MPH, MSCEPrincipal InvestigatorDivision of Infectious Diseases, Department of Medicine, University of Pennsylvania
2 Previous Clinical Trials
1,509 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Penn Microbiome Therapy (PMT) for Severe-Clostridium Difficile Infection (CDI)
2020. "Penn Microbiome Therapy (PMT) for Severe-Clostridium Difficile Infection (CDI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03970200.
~3 spots leftby Apr 2025
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