Infection Due to Resistant OrganismPhase 1FMTNCT02816437
FMT for MDRO Colonization in Solid Organ Transplant
A Phase 1 study testing OpenBiome Fecal Microbiota Transplantation retention enema in people with Infection Due to Resistant Organism, run by University of Miami.
Trial summary
This is a pilot feasibility study to determine whether fecal microbiota transplantation (FMT) can suppress or reverse gastrointestinal carriage of MDROs in hospitalized solid organ transplant recipients with a history of one or more MDRO infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection Due to Resistant Organism
- What is being tested?
- OpenBiome Fecal Microbiota Transplantation retention enema
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Solid organ transplant recipients: liver, intestinal, multivisceral transplants, heart, lung, pancreas or kidney transplant recipients
- Transplant recipient at least >30 days post solid organ-transplant
- Transplant recipient must be available locally for follow up to 6-months post FMT transplant
- Inpatient status at time of FMT
- History of at least one or more treated infections in the last 90 days (bacteremia, UTI, pneumonia or abdominal collection with a positive culture with MDRO) due to an MDRO and the MDRO is likely of enteric origin (carbapenem resistant enterobacteriaceae (CRE), vancomycin resistant enterococci (VRE) or carbapenem resistant Pseudomonas (CRP).
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- Be without active infection for >15 days: bacteremia, UTI, pneumonia or abdominal collection.
- Be without a positive culture (except for stool) with MDRO (carbapenem resistant enterobacteriaceae (CRE), vancomycin resistant enterococci (VRE) or carbapenem resistant Pseudomonas (CRP)
- Patients are not receiving antimicrobials (therapeutic or suppressive) within 48 hours of FMT
- Solid organ prophylactic antimicrobials as per protocol will be held 24 hours before and 14 days post FMT e.g. trimethoprim/sulfamethoxazole 3x/week or dapsone 100 mg PO daily or weekly for PJP prophylaxis
- Ganciclovir or valgancyclovir for CMV prophylaxis if required as per protocol can be continued.
- Patients have a positive surveillance rectal culture for evidence of colonization.
Who cannot join
- Inability to provide informed consent
- Physician-documented, severe allergy to nuts or other food allergens
- Patients with allergies to ingredients Generally Recognized As Safe " glycerol, sodium chloride
- Study participants hospitalized in the intensive care unit
- CMV IgG, EBV IgG and PCR negative at the time of consent
- Biological MELD score > 28 as defined by transplant surgeon
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- Pregnancy or inability/unwillingness to use contraceptives.
- Autoimmune hepatitis
- Patients that received a new solid organ transplant within the last 30 days at the time of enrollment
- Patients on antibiotics treating an active infection or less than 2 weeks at the time of enrollment
- Any circulatory failure on vasopressors
- Respiratory failure (on mechanical ventilation) at the time of enrollment
- Renal failure (GFR <30 or dialysis) at the time of enrollment
- Any active Clostridium difficile infection regardless of severity
- Post-allogeneic hematopoietic stem cell transplant recipients
- ANC <1000/mm3
- HIV+ controlled or not well controlled on antiretroviral therapy
- At increased risk for peritonitis: presence of intra-abdominal devices, peritoneal dialysis.
- Previous FMT
- Patients undergoing treatment for liver or any other organ transplant rejection
- Patients with graft vs. host disease
- Patients with any active infection (bacteremia, pneumonia, urinary tract infection or abscess)
- Life expectancy <1-year post transplant
- Any clinical significant bleeding from a lower GI source (as defined as requiring blood transfusion, endoscopy or surgical or radiologic intervention) in the last 30 days.
- Any condition that the physician investigators deems unsafe, feel the risks of 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: Fecal Microbiota Transplantation for the Treatment of Multidrug-Resistant Organism Colonization in Solid Organ Transplant Recipients
This is a pilot feasibility study to determine whether fecal microbiota transplantation (FMT) can suppress or reverse gastrointestinal carriage of MDROs in hospitalized solid organ transplant recipients with a history of one or more MDRO infections.
Read the detailed description
This is a pilot feasibility study to determine whether fecal microbiota transplantation (FMT) can suppress or reverse gastrointestinal carriage of MDROs in hospitalized solid organ transplant recipients with a history of one or more MDRO infections.
Study participants who meet inclusion/exclusion criteria and provide written, informed consent will provide a pre-FMT stool sample. Participants will be followed from the time of enrollment up to 3 months post FMT.
Specific organisms of interest that will be tested for by the stool cultures include vancomycin resistant enterococcus, carbapenem resistant Enterobacteriaceae and carbapenem resistant Pseudomonas. Eligible patients who demonstrate colonization with a positive culture for a specific organism of interest will be given FMT.
One FMT dose of a retention rectal enema (OpenBiome) will be administered by a nurse and supervised by our principal investigator and/or sub-investigators trained in performance of FMT.
Stool samples of study participants will be collected and analyzed as follows:
- Pre-FMT: Stool collection \& storage in glycerol/flash frozen, to be shipped in dry ice
- 48 hours post FMT: Stool collection using RNA later kit provided by OpenBiome (in hospital)
- Day 7: Stool collection \& storage in glycerol/flash frozen, to be shipped in dry ice
- Day 14: Stool collection using RNAlater kit (at home)
- Day 30: Stool collection \& storage in glycerol/flash frozen (in hospital or clinic), to be shipped in dry ice
- Day 90: follow-up visit in clinic, final sample collected using RNAlater kit
- Conditions
- Infection Due to Resistant Organism
- Being tested
- OpenBiome Fecal Microbiota Transplantation retention enema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpenBiome Fecal Microbiota Transplantation retention enemaBiological
Also called Frozen Fecal Enema "OpenBiome"
Keep enema frozen until ready for administration. A single transfer of all 250mL of fecal material using universal precautions to a standard retention enema bag over 1 hour with material retained for at least 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| OpenBiome FMT retention enema | Experimental | OpenBiome Fecal Microbiota Transplantation retention enema, one rectal application. Receives: Biological: OpenBiome Fecal Microbiota Transplantation retention enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Overall rates of adverse events
Measured: 10 months
Secondary outcomes (2)
Rate of MDRO decolonization
Number of successful cases of MDRO decolonization
Measured: 10 months
Rate of Recurrent MDRO infections
Number of patients with recurrent MDRO infections
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: safety
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection Due to Resistant OrganismStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilian Abbo, University of Miami
- Investigators
- Lilian Abbo, M.D, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816437
- Sponsor's protocol ID
- 20160351
- Acronym
- FMT
- Status last verified
- May 2020
- First submitted
- 10 Jun 2016
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation for the Treatment of Multidrug-Resistant Organism Colonization in Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT02816437
- Acronym / sponsor ID
- FMT / 20160351
- Conditions
- Infection Due to Resistant Organism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: safety
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot feasibility study to determine whether fecal microbiota transplantation (FMT) can suppress or reverse gastrointestinal carriage of MDROs in hospitalized solid organ transplant recipients with a history of one or more MDRO infections.
Detailed description
This is a pilot feasibility study to determine whether fecal microbiota transplantation (FMT) can suppress or reverse gastrointestinal carriage of MDROs in hospitalized solid organ transplant recipients with a history of one or more MDRO infections.
Study participants who meet inclusion/exclusion criteria and provide written, informed consent will provide a pre-FMT stool sample. Participants will be followed from the time of enrollment up to 3 months post FMT.
Specific organisms of interest that will be tested for by the stool cultures include vancomycin resistant enterococcus, carbapenem resistant Enterobacteriaceae and carbapenem resistant Pseudomonas. Eligible patients who demonstrate colonization with a positive culture for a specific organism of interest will be given FMT.
One FMT dose of a retention rectal enema (OpenBiome) will be administered by a nurse and supervised by our principal investigator and/or sub-investigators trained in performance of FMT.
Stool samples of study participants will be collected and analyzed as follows:
- Pre-FMT: Stool collection \& storage in glycerol/flash frozen, to be shipped in dry ice
- 48 hours post FMT: Stool collection using RNA later kit provided by OpenBiome (in hospital)
- Day 7: Stool collection \& storage in glycerol/flash frozen, to be shipped in dry ice
- Day 14: Stool collection using RNAlater kit (at home)
- Day 30: Stool collection \& storage in glycerol/flash frozen (in hospital or clinic), to be shipped in dry ice
- Day 90: follow-up visit in clinic, final sample collected using RNAlater kit
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OpenBiome FMT retention enema | Experimental | Biological: OpenBiome Fecal Microbiota Transplantation retention enemaOpenBiome Fecal Microbiota Transplantation retention enema, one rectal application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years old
- Solid organ transplant recipients: liver, intestinal, multivisceral transplants, heart, lung, pancreas or kidney transplant recipients
- Transplant recipient at least >30 days post solid organ-transplant
- Transplant recipient must be available locally for follow up to 6-months post FMT transplant
- Inpatient status at time of FMT
Key exclusion criteria (25 listed)
- Inability to provide informed consent
- Physician-documented, severe allergy to nuts or other food allergens
- Patients with allergies to ingredients Generally Recognized As Safe " glycerol, sodium chloride
- Study participants hospitalized in the intensive care unit
- CMV IgG, EBV IgG and PCR negative at the time of consent
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 |
|---|---|---|
| OpenBiome Fecal Microbiota Transplantation retention enemaAlso: Frozen Fecal Enema "OpenBiome"Keep enema frozen until ready for administration. A single transfer of all 250mL of fecal material using universal precautions to a standard retention enema bag over 1 hour with material retained for at least 1 hour. | Biological | OpenBiome FMT retention enema |
Primary outcome
Number of participants with adverse events
Time frame: 10 months
Overall rates of adverse events
2 secondary outcomes
Rate of MDRO decolonization
Time frame: 10 months
Rate of Recurrent MDRO infections
Time frame: 10 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Individual participant dataSharing planned: No
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.
Lilian Abbo, M.D principal investigator
University of Miami
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OpenBiome Fecal Microbiota Transplantation retention enema in people with Infection Due to Resistant Organism, run by University of Miami.
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 12 inclusion and 25 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: withdrawn, as of the sponsor's last update on 26 May 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of participants with adverse events (time frame: 10 months). 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 26 May 2020.