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Recurrent Urinary Tract InfectionEarly Phase 1NCT03050515

Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract Infections

A Early Phase 1 study testing Fecal Microbiota Transplantation in people with Recurrent Urinary Tract Infection, run by University of California, Irvine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Recurrent urinary tract infections are quickly becoming a public health obstacle in our aging population. Almost 50% of women have at least one urinary tract infection in their lifetime; following this first infection, there is a 25-35% chance that she will have another infection in the subsequent 3-6 months. Read more about this study

Who is it for?
Ages 18 to 100 years, women onlyHealthy volunteers can take part
Conditions the study is for
Recurrent Urinary Tract Infection
What is being tested?
Fecal Microbiota Transplantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
5 Feb 2018to 23 Feb 2020
Phase
Early 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 to 100 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCI Women's Healthcare Center

    Orange, California, 92868

Other trials in United States

About this study

Official title: Fecal Microbiota Transplantation for the Treatment of Recurrent Urinary Tract

Recurrent urinary tract infections are quickly becoming a public health obstacle in our aging population. Almost 50% of women have at least one urinary tract infection in their lifetime; following this first infection, there is a 25-35% chance that she will have another infection in the subsequent 3-6 months. With each documented infection, a patient receives anywhere from a three to seven day course of antibiotics for treatment. Repeated courses of antibiotics often lead to the development of multi-drug resistant infections that are difficult to treat with our arsenal of oral medications. It is theorized that most, if not all, urinary tract infections are caused by bacteria from the gastrointestinal tract. If there is a generalized gut dysbiosis due to repeated courses of oral antibiotics, it will likely be difficult to ever adequately treat repeat urinary tract infections. This same theory led to the development and utilization of fecal microbiota transplantation in the treatment of refractory Clostridium difficile diarrhea. There are now several studies that have reported on the efficacy of fecal transplantation in the treatment of C.difficile infections as well as the correction of gut dysbiosis. Given this positive response in treatment of refractory infectious diarrhea, the investigators propose that the correction of gut dysbiosis can also treat refractory recurrent urinary tract infections. Therefore, the investigators propose this pilot study to determine the effectiveness of fecal transplantation in the treatment of refractory, recurrent urinary tract infections.

Being tested
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 TransplantationBiological

    Also called FMT, Fecal Transplant

    This is a single arm study. All participants will receive a single fecal transplant to determine effectiveness in treating refractory recurrent urinary tract infections.

Study groups in NCT03050515
Study groupRoleWhat they receive
Fecal TransplantExperimentalEnrolled 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.
Receives: Biological: Fecal Microbiota Transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in frequency of culture proven urinary tract infections following fecal transplant

    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.

    Measured: 6 months

Secondary outcomes (2)

  1. Efficacy of fecal transplant in transforming recurrent urinary tract infection bacteria profile to that of pan-sensitive organisms on urine culture specimens

    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.

    Measured: 6 months

  2. Change in the gut microbiome following fecal transplantation measured via 16s sequencing of stool samples

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2017
  2. Study start5 Feb 2018
  3. Primary completion30 Jun 2019
  4. Study completion23 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03050515
Sponsor's protocol ID
2017-3541
Status last verified
Jun 2020
First submitted
3 Feb 2017
Last updated
18 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jeney SES, Avelar-Barragan J, Whiteson K, Chang J, Dutta S, Lane F. Fecal Putative Uropathogen Abundance and Antibiotic Resistance Gene Carriage in Women With Refractory Recurrent Urinary Tract Infection Treated With Fecal Microbiota Transplantation. Female Pelvic Med Reconstr Surg. 2022 Apr 1;28(4):213-219. doi: 10.1097/SPV.0000000000001090. Epub 2021 Oct 1.

    PubMed 34608030

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Fecal Microbiota Transplantation in people with Recurrent Urinary Tract Infection, run by University of California, Irvine 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 3 inclusion and 8 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 Jun 2020. 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 phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in frequency of culture proven urinary tract infections following fecal transplant (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03050515, which also lists 1 linked publication.

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 Jun 2020.

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