Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract Infections
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|ClinicalTrials.gov Identifier: NCT03050515|
Recruitment Status : Active, not recruiting
First Posted : February 13, 2017
Last Update Posted : February 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Urinary Tract Infection||Biological: Fecal Microbiota Transplantation||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract|
|Actual Study Start Date :||February 5, 2018|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
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.
Biological: Fecal Microbiota Transplantation
This is a single arm study. All participants will receive a single fecal transplant to determine effectiveness in treating refractory recurrent urinary tract infections.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050515
|United States, California|
|UCI Women's Healthcare Center|
|Orange, California, United States, 92868|
|Principal Investigator:||Felicia Lane, MD||University of California, Irvine|