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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
| University of Pennsylvania | OTHER |
| Duke University | OTHER |
| Rush University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT for MDRO UTI | Experimental | Participants with eligible MDRO UTIs will receive FMT (150mL of RBX2660) via enema. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal microbiota transplant | Drug | 150mL of FMT product RBX2660 delivered via enema |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Six months post-FMT |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Recurrent UTI Post-FMT | Risk of recurrent UTI post-FMT will be evaluated | Six months post-FMT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erik Dubberke, MD, MSPH | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | FMT for MDRO UTI | Participants with eligible MDRO UTIs will receive FMT (150mL of RBX2660) via enema. Fecal microbiota transplant: 150mL of FMT product RBX2660 delivered via enema |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FMT for MDRO UTI | Participants with eligible MDRO UTIs will receive FMT (150mL of RBX2660) via enema. Fecal microbiota transplant: 150mL of FMT product RBX2660 delivered via enema |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Six months post-FMT |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FMT for MDRO UTI | Participants with eligible MDRO UTIs will receive FMT (150mL of RBX2660) via enema. Fecal microbiota transplant: 150mL of FMT product RBX2660 delivered via enema |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kimberly Reske, Research Coordinator | Washington University in St. Louis School of Medicine | 3147474041 | kreske@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2018 | Jan 26, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| OTHER |
| Rebiotix Inc. | INDUSTRY |
Participants with eligible MDRO UTIs will receive FMT.
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Number of Patients With Recurrent UTI Post-FMT | Risk of recurrent UTI post-FMT will be evaluated | Posted | Count of Participants | Participants | Six months post-FMT |
|
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| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |