Status:
COMPLETED
FMT for Multidrug Resistant Organism Reversal
Lead Sponsor:
Washington University School of Medicine
Conditions:
Infection With Multi-drug Resistant Organisms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This proposed protocol involves the use of the fecal microbiota transplantation (FMT) to suppress or reverse colonization with multidrug resistant organisms (MDRO) in subjects with recurrent MDRO infe...
Detailed Description
This is a prospective pilot study of fecal microbiota transplantation in patients with a history of recurrent MDRO infections. Subjects who meet inclusion/exclusion criteria and provide written, infor...
Eligibility Criteria
Inclusion
- Inclusion criteria will include:
- Age ≥18 years old.
- Outpatient status at time of FMT.
- History of at least three recurrent infections due to an MDRO; at least two recurrent, severe infections due to MDRO requiring hospitalization; or at least two recurrent infections due to MDRO for which only antimicrobials with rate limiting toxicities (see above) are available AND the MDRO is likely of enteric origin. Only MDROs of likely enteric origin will be included.
- Be without active infection due to the MDRO at the time of FMT.
- Not be receiving antimicrobials (therapeutic or suppressive) within 48 hours of FMT.
- Exclusion criteria will include:
- Subjects \<18 years old.
- Subjects unable to be seen as an outpatient.
- Use of enteral or systemic antimicrobials at time of FMT.
- Planned use of enteral or systemic antimicrobials up to 6 months post-FMT.
- Pregnancy or inability/unwillingness to use contraceptives.
- Recent intra-abdominal surgery
- Short gut syndrome
- Gastrointestinal motility disorders
- Use of medications that affect intestinal motility an inability to cease using those medications at the time of FMT.
- Post-allogeneic hematopoietic stem cell transplant recipients with previous or current gastrointestinal graft versus host disease.
- ANC \<500/mm3
- HIV+ and not well controlled on antiretroviral therapy, or CD4+ \<200/ mm3
- At increased risk for peritonitis: presence of intra-abdominal devices, receiving peritoneal dialysis, or ascites.
- Any acute illness
- Recurrent C. difficile infection.
- Unlikely to survive for 3 months.
- Investigator feels the risks of FMT outweigh potential benefit, including other conditions or medications that the investigator determines puts the subject at greater risk from FMT.
Exclusion
Key Trial Info
Start Date :
August 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT02312986
Start Date
August 1 2015
End Date
July 31 2020
Last Update
February 24 2021
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