- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03050515
Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract Infections
Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Orange, California, United States, 92868
- UCI Women's Healthcare Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- English speaking
- Meet criteria for recurrent urinary tract infections A. Each infection with bacterial colony count of greater than 100,000 AND B. 2 culture proven urinary tract infections within the preceding 6 months or culture proven urinary tract infections within the preceding 12 months
- Failed conservative management of recurrent urinary tract infections A. Completed 6-month trial of Macrobid, Trimethoprim or Methenamine suppression OR B. Completed 6-week series of intravesical instillations with DMSO or heparin/lidocaine
Exclusion Criteria:
- Pregnant
- Managed with a colostomy
- Managed with a suprapubic catheter
- Known renal abscess
- Acute or chronic renal failure
- Cardiac disease
- Rectal prolapse or bleeding
- Colon surgery in preceding 12 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fecal Transplant
Enrolled and screened patients will receive a donor directed fecal transplant via retention enema. This procedure will take place at the University of California Irvine Women's Health Center on the day of the participant's choosing. The day prior to the procedure, the participant will undergo a bowel prep and stop all prophylactic antibiotics. On the day of procedure, the patient will present to the clinic and undergo a simple, retention enema. This procedure takes about 30-40 minutes to complete and does not require any anesthesia or sedation. |
This is a single arm study.
All participants will receive a single fecal transplant to determine effectiveness in treating refractory recurrent urinary tract infections.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in frequency of culture proven urinary tract infections following fecal transplant
Time Frame: 6 months
|
Recurrent urinary tract infections are defined as 2 or more urine culture proven urinary tract infections in 6 months or 3 or more culture proven urinary tract infections in 12 months.
To assess complete treatment success following fecal transplant, the investigators will collect urine cultures 1 month, 3 months and 6 months after fecal transplantation, as well as with any symptoms of a urinary tract infection, to determine the frequency of culture proven urinary tract infections over a 6 month time period following fecal transplant.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of fecal transplant in transforming recurrent urinary tract infection bacteria profile to that of pan-sensitive organisms on urine culture specimens
Time Frame: 6 months
|
Often, patients with refractory recurrent urinary tract infection become infected with bacteria that are multi-drug resistant and therefore difficult to treat.
To assess if a fecal transplant can alter the bacterial antibiotic susceptibility profile, the investigators will evaluate urine cultures 1 month, 3 months and 6 months after fecal transplant to test for infection and then to assess the antibiotic resistance profile.
|
6 months
|
Change in the gut microbiome following fecal transplantation measured via 16s sequencing of stool samples
Time Frame: 6 months
|
The gut microbiome is an evolving field of research, especially following a fecal transplant.
The investigators will collect a stool sample prior to fecal transplant and then at regular intervals following fecal transplant (1 day, 1 week, 1 month, 3 months and 6 months post-transplantation) to determine how a patient's gut microbiomes (via 16s sequencing) is affected by fecal transplantation.
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-3541
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recurrent Urinary Tract Infection
-
Lawson Health Research InstituteUniversity of Western Ontario, CanadaCompletedUrinary Tract Infection | Recurrent Urinary Tract InfectionCanada
-
Radboud University Medical CenterIBSA Institut Biochimique SA; Goodlife Pharma B.V.RecruitingRecurrent Urinary Tract InfectionNetherlands
-
University of SulaimaniCompletedRecurrent Urinary Tract InfectionIraq
-
IRCCS Policlinico S. MatteoCompleted
-
Beijing Institute of Disease Control and PreventionUnknownRecurrent Urinary Tract InfectionChina
-
University of California, San DiegoNYU Langone Health; American Urogynecologic SocietyCompletedRecurrent Urinary Tract InfectionUnited States
-
Hvidovre University HospitalRecruitingRecurrent Urinary Tract InfectionDenmark
-
Atlantic Health SystemNot yet recruitingRecurrent Urinary Tract Infection
-
Medical University of GrazCompletedRecurrent Urinary Tract InfectionAustria
-
Danone ResearchCompletedRecurrent Urinary Tract InfectionBulgaria
Clinical Trials on Fecal Microbiota Transplantation
-
Madhusudan (Madhu) Grover, MBBSRecruiting
-
Medical University of GrazBristol-Myers SquibbTerminatedMalignant Melanoma Stage III | Malignant Melanoma Stage IV | Fecal Microbiota TransplantationAustria
-
Children's Mercy Hospital Kansas CityUniversity of Pittsburgh; Stanford UniversityCompletedUlcerative Colitis (UC) | Inflammatory Bowel Diseases (IBD) | Crohn's Disease (CD)United States
-
The Second Hospital of Nanjing Medical UniversitySIR RUN RUN hospital of Nanjing Medical UniversityNot yet recruitingAttention-deficit/Hyperactivity DisorderChina
-
The Second Hospital of Nanjing Medical UniversityNot yet recruiting
-
The Second Hospital of Nanjing Medical UniversitySIR RUN RUN hospital of Nanjing Medical UniversityRecruiting
-
The First Affiliated Hospital of Nanchang UniversityCompletedAcute Pancreatitis | Intestinal Bacteria Flora Disturbance | Fecal Microbiota Transplantation | Intestinal DysfunctionChina
-
The Second Hospital of Nanjing Medical UniversityRecruitingCancer | Intestinal ComplicationsChina
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingAllogeneic Hematopoietic Stem CellUnited States
-
The Second Hospital of Nanjing Medical UniversityWithdrawnCOVID-19 Complicated With Refractory Intestinal InfectionsChina