Back to resultsFMT for Multidrug Resistant Organism Reversal
Primary Purpose
Infection With Multi-drug Resistant Organisms
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Fecal microbiota transplantation (FMT)
Sponsored by
About this trial
This is an interventional treatment trial for Infection With Multi-drug Resistant Organisms focused on measuring infection, colonization, antibiotic resistance
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fecal microbiota transplantation
Arm Description
Subjects will receive 150mL of fecal microbiota product via enema.
Outcomes
Primary Outcome Measures
Safety of FMT in Patients With Recurrent MDRO Infections (Incidence and Severity of Solicited and Serious Adverse Events)
Incidence and severity of solicited and serious adverse events within 12 months of FMT.
Secondary Outcome Measures
MDRO Infection Status Post-FMT (Number of Subjects With MDRO Infections)
Number of subjects with MDRO infections 30 days, 6 months, and 12 months post-FMT.
Full Information
NCT ID
NCT02312986
First Posted
December 4, 2014
Last Updated
February 8, 2021
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02312986
Brief Title
FMT for Multidrug Resistant Organism Reversal
Official Title
Use of Fecal Microbiota Transplantation (FMT) to Reverse Multi-Drug Resistant Organism Carriage
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
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, informed consent will provide a pre-FMT stool sample. The FMT will be administered by enema in the outpatient setting by trained personnel. Patients will provide stool samples 30 days, 6 months, and 12 months post-FMT. The subjects will also be monitored for potential adverse events, recurrence of MDRO infections, infections that may be related to FMT, and worsening of existing comorbidities or development of new comorbidities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection With Multi-drug Resistant Organisms
Keywords
infection, colonization, antibiotic resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fecal microbiota transplantation
Arm Type
Experimental
Arm Description
Subjects will receive 150mL of fecal microbiota product via enema.
Intervention Type
Biological
Intervention Name(s)
Fecal microbiota transplantation (FMT)
Other Intervention Name(s)
FMT, stool transplant
Intervention Description
Prospective pilot study to examine whether fecal microbiota transplantation (FMT) is able to suppress or reverse gastrointestinal carriage of multi-drug resistant organisms.
Primary Outcome Measure Information:
Title
Safety of FMT in Patients With Recurrent MDRO Infections (Incidence and Severity of Solicited and Serious Adverse Events)
Description
Incidence and severity of solicited and serious adverse events within 12 months of FMT.
Time Frame
12 months post-FMT
Secondary Outcome Measure Information:
Title
MDRO Infection Status Post-FMT (Number of Subjects With MDRO Infections)
Description
Number of subjects with MDRO infections 30 days, 6 months, and 12 months post-FMT.
Time Frame
30 days, 6 months, and 12 months post-FMT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik R Dubberke, MD, MSPH
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
FMT for Multidrug Resistant Organism Reversal
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