Phase 1
N=1
FMT for Multidrug Resistant Organism Reversal
Infection With Multi-drug Resistant Organisms
Bottom Line
View on ClinicalTrials.gov: NCT02312986 ↗Enrolled (actual)
1
Serious AEs
100.0%
Results posted
Feb 2021
Primary outcome: Primary: Safety of FMT in Patients With Recurrent MDRO Infections (Incidence and Severity of Solicited and Serious Adverse Events) — 0; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Fecal microbiota transplantation (FMT) (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of FMT in Patients With Recurrent MDRO Infections (Incidence and Severity of Solicited and Serious Adverse Events) |
0; 1 | — |
| SECONDARY MDRO Infection Status Post-FMT (Number of Subjects With MDRO Infections) |
0; 1; 0 | — |
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 infections due to organisms of likely enteric origin.
FMT will be performed on subjects with a history of at least three recurrent infections due to 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 are available.
The objective of this protocol is to determine if fecal microbiota transplantation (FMT) will be able to prevent additional recurrences of infections due to MDRO by suppressing or reversing enteric colonization with MDRO.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02312986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.