Infection With Multi-drug Resistant OrganismsPhase 1NCT02312986
FMT for Multidrug Resistant Organism Reversal
A Phase 1 study testing Fecal microbiota transplantation (FMT) in people with Infection With Multi-drug Resistant Organisms, run by Washington University School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection With Multi-drug Resistant Organisms
- What is being tested?
- Fecal microbiota transplantation (FMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to 31 Jul 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
About this study
Official title: Use of Fecal Microbiota Transplantation (FMT) to Reverse Multi-Drug Resistant Organism Carriage
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.
Read the 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.
- Being tested
- Fecal microbiota transplantation (FMT)
- Keywords
- infection, colonization, antibiotic resistance
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantation (FMT)Biological
Also called FMT, stool transplant
Prospective pilot study to examine whether fecal microbiota transplantation (FMT) is able to suppress or reverse gastrointestinal carriage of multi-drug resistant organisms.
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbiota transplantation | Experimental | Subjects will receive 150mL of fecal microbiota product via enema. Receives: Biological: Fecal microbiota transplantation (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post-FMT
Secondary outcomes (1)
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.
Measured: 30 days, 6 months, and 12 months post-FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startAug 2015
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infection With Multi-drug Resistant OrganismsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erik R Dubberke, MD, MSPH, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312986
- Sponsor's protocol ID
- 201506131
- Status last verified
- Feb 2021
- First submitted
- 4 Dec 2014
- Last updated
- 24 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Fecal Microbiota Transplantation (FMT) to Reverse Multi-Drug Resistant Organism Carriage
- ClinicalTrials.gov ID
- NCT02312986
- Acronym / sponsor ID
- 201506131
- Keywords
- infection, colonization, antibiotic resistance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Posted 24 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecal microbiota transplantation | Experimental | Biological: Fecal microbiota transplantation (FMT)Subjects will receive 150mL of fecal microbiota product via enema. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbiota transplantation (FMT)Also: FMT, stool transplantProspective pilot study to examine whether fecal microbiota transplantation (FMT) is able to suppress or reverse gastrointestinal carriage of multi-drug resistant organisms. | Biological | Fecal microbiota transplantation |
Primary outcome
Safety of FMT in Patients With Recurrent MDRO Infections (Incidence and Severity of Solicited and Serious Adverse Events)
Time frame: 12 months post-FMT
Incidence and severity of solicited and serious adverse events within 12 months of FMT.
1 secondary outcome
MDRO Infection Status Post-FMT (Number of Subjects With MDRO Infections)
Time frame: 30 days, 6 months, and 12 months post-FMT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Infection With Multi-drug Resistant Organisms
RecruitingObservational study
Infection Risk Associated With Digestive MDRO Carriage in Hospitalized Patients
Multi Drug Resistant Organisms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik R Dubberke, MD, MSPH principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fecal microbiota transplantation (FMT) in people with Infection With Multi-drug Resistant Organisms, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of FMT in Patients With Recurrent MDRO Infections (Incidence and Severity of Solicited and Serious Adverse Events) (time frame: 12 months post-FMT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.