Urinary Tract InfectionsPhase 1/2NCT03367910
Fecal Microbiota Transplantation (FMT) for MDRO UTI
A Phase 1/2 study testing Fecal microbiota transplant in people with Urinary Tract Infections, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and impact of fecal microbiota transplantation (FMT) on the fecal and urine microbiome, urine metabolome, risk of recurrent urinary tract infection (UTI), and persistent multidrug resistant organism (MDRO) colonization of patients with a history of recurrent MDRO… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Fecal microbiota transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2018to 31 Dec 2021
- Phase
- Phase 1/2
- 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 UTIs 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.
- 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
- Age <18 years
- Inpatient status at time of FMT
- Ineligible UTI
- >1 organism in urine (other than minimal contaminants)
- Decline to participate
- Recurrent Clostridium difficile infection
Show all 30Show fewer
- Presence of intra-abdominal devises
- Neutropenia (ANC <500 mm3)
- Intestinal mucosal disruption
- Unlikely to survive 6 months
- Pregnancy or unwillingness to use contraceptives
- Short gut syndrome
- Use of medications that affect intestinal motility
- Gastrointestinal motility disorder
- Inflammatory bowel disease
- Recent abdominal surgery
- Active typhlitis
- Active diverticulitis
- Current gastrointestinal graft versus host disease
- HIV with lack of antiretroviral therapy (ART)
- CD4 count <200 mm3
- Peritoneal dialysis
- Cirrhosis with ascites
- Active intra-abdominal malignancy
- Presence of chronic indwelling foley catheter, chronic suprapubic catheter, or ileal conduit
- Active hepatitis C
- Active hepatitis B
- Presence of ureteral stent
- Active kidney stone that is believed to be a persistent source of bacterial colonization
- Any condition where the investigator feels the risks of FMT outweigh the benefits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fecal Microbiota Transplantation Using RBX2660 for the Prevention of Recurrent Urinary Tract Infections Due to Multidrug Resistant Organisms
The purpose of this study is to determine the safety and impact of fecal microbiota transplantation (FMT) on the fecal and urine microbiome, urine metabolome, risk of recurrent urinary tract infection (UTI), and persistent multidrug resistant organism (MDRO) colonization of patients with a history of recurrent MDRO UTIs. This is an open label phase 1-2 study.
Read the detailed description
Multidrug resistant organism (MDRO) infections are increasingly common. The most common type of infection caused by MDROs is urinary tract infections (UTIs). Many MDROs are inhabitants of the colon, and MDROs can contaminate the periurethral area and migrate to the bladder. Patients with MDRO UTI frequently experience multiple relapses and hospitalizations, which both increase the individual's morbidity and mortality and leads to additional MDRO nosocomial spread. There are few options available to prevent MDRO UTIs, and there are limited strategies to identify patients at risk for recurrent MDRO UTI and prevent or reverse MDRO colonization. A potential novel method to reverse MDRO colonization and prevent recurrent UTI would be by repopulating the gut microbiome with "healthy" microbiota by fecal microbiota transplantation (FMT).
In this study, participants with a history of severe, recurrent MDRO UTI will receive FMT. Participants will submit stool and urine specimens pre- and post-FMT, and the effect of FMT on the participants' fecal and urine microbiome, urine metabolome, persistent MDRO colonization, and risk of recurrent UTI will be evaluated.
- Conditions
- Urinary Tract Infections
- Being tested
- Fecal microbiota transplant
- Keywords
- Urinary tract infection, Multidrug resistant organism, Fecal microbiota transplantation
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantDrug
Also called Stool transplant
150mL of FMT product RBX2660 delivered via enema
| Study group | Role | What they receive |
|---|---|---|
| FMT for MDRO UTI | Experimental | Participants with eligible MDRO UTIs will receive FMT (150mL of RBX2660) via enema. Receives: Drug: Fecal microbiota transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Adverse Events During and After FMT
The number, types, severity, and relation of adverse events to study procedures or product will be analyzed.
Measured: Six months post-FMT
Secondary outcomes (1)
Number of Patients With Recurrent UTI Post-FMT
Risk of recurrent UTI post-FMT will be evaluated
Measured: Six 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 posted11 Dec 2017
- Study start8 Feb 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
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 Urinary Tract InfectionsStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants with eligible MDRO UTIs will receive FMT.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, University of Pennsylvania, Duke University, Rush University, Rebiotix Inc.
- Responsible party
- Sponsor
- Investigators
- Erik Dubberke, MD, MSPH, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367910
- Sponsor's protocol ID
- 201708204
- Status last verified
- Mar 2022
- First submitted
- 5 Dec 2017
- Last updated
- 18 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation Using RBX2660 for the Prevention of Recurrent Urinary Tract Infections Due to Multidrug Resistant Organisms
- ClinicalTrials.gov ID
- NCT03367910
- Acronym / sponsor ID
- 201708204
- Conditions
- Urinary Tract Infections
- Keywords
- Urinary tract infection, Multidrug resistant organism, Fecal microbiota transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, University of Pennsylvania, Duke University, Rush University, Rebiotix Inc.
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Posted 28 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and impact of fecal microbiota transplantation (FMT) on the fecal and urine microbiome, urine metabolome, risk of recurrent urinary tract infection (UTI), and persistent multidrug resistant organism (MDRO) colonization of patients with a history of recurrent MDRO UTIs. This is an open label phase 1-2 study.
Detailed description
Multidrug resistant organism (MDRO) infections are increasingly common. The most common type of infection caused by MDROs is urinary tract infections (UTIs). Many MDROs are inhabitants of the colon, and MDROs can contaminate the periurethral area and migrate to the bladder. Patients with MDRO UTI frequently experience multiple relapses and hospitalizations, which both increase the individual's morbidity and mortality and leads to additional MDRO nosocomial spread. There are few options available to prevent MDRO UTIs, and there are limited strategies to identify patients at risk for recurrent MDRO UTI and prevent or reverse MDRO colonization. A potential novel method to reverse MDRO colonization and prevent recurrent UTI would be by repopulating the gut microbiome with "healthy" microbiota by fecal microbiota transplantation (FMT).
In this study, participants with a history of severe, recurrent MDRO UTI will receive FMT. Participants will submit stool and urine specimens pre- and post-FMT, and the effect of FMT on the participants' fecal and urine microbiome, urine metabolome, persistent MDRO colonization, and risk of recurrent UTI will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants with eligible MDRO UTIs will receive FMT.
| Arm | Type | Receives |
|---|---|---|
| FMT for MDRO UTI | Experimental | Drug: Fecal microbiota transplantParticipants with eligible MDRO UTIs will receive FMT (150mL of RBX2660) 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 UTIs 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.
- 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 (30 listed)
- Age <18 years
- Inpatient status at time of FMT
- Ineligible UTI
- >1 organism in urine (other than minimal contaminants)
- Decline to participate
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 transplantAlso: Stool transplant150mL of FMT product RBX2660 delivered via enema | Drug | FMT for MDRO UTI |
Primary outcome
Number of Patients With Adverse Events During and After FMT
Time frame: Six months post-FMT
The number, types, severity, and relation of adverse events to study procedures or product will be analyzed.
1 secondary outcome
Number of Patients With Recurrent UTI Post-FMT
Time frame: Six months post-FMT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 Dubberke, MD, MSPH principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fecal microbiota transplant in people with Urinary Tract Infections, run by Washington University School of Medicine at 1 site in United States.
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 30 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 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 28 Feb 2022). 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?
Number of Patients With Adverse Events During and After FMT (time frame: Six 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 18 Mar 2022.