Phage Therapy for Urinary Tract Infections in Spinal Cord Injury

(Phage Trial)

Overseen By Barbara W Trautner, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Barbara Wells Trautner

Must not be taking: Urine acidifiers

Disqualifiers: Neutropenia, Organ transplant, HIV, others

Compensation: Varies

Number of Visits: 17

Duration: 7 days

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called phage therapy for individuals with spinal cord injuries who have urinary tract infections. Phage therapy uses viruses that specifically target and kill bacteria, and the study aims to determine its safety and effectiveness. Participants will receive either the phage solution or a placebo (a harmless substance) through their catheter twice a day for a week. It is suitable for adults with spinal cord injuries who require catheters due to bladder issues and have bacteria in their urine but show no infection symptoms. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial protocol does not clearly specify if you need to stop taking your current medications. However, it mentions that prescription drugs, over-the-counter medications, and supplements that acidify the urine are excluded unless deemed acceptable by the sponsor-investigator.

Is there any evidence suggesting that phage therapy is likely to be safe for humans?

Research has shown that phage therapy is generally safe and well-tolerated for treating urinary tract infections (UTIs). It offers a promising option, especially when traditional treatments fail due to drug resistance. Recent studies have reported positive safety results for patients with recurring UTIs.

Phage therapy specifically targets harmful bacteria, sparing beneficial bacteria and reducing potential side effects. Although still under study, current data suggest it could be a safe option for managing UTIs, even for individuals with spinal cord injuries.

This trial is in an early stage, focusing on ensuring the treatment's safety for humans. While phage therapy is not yet approved for UTIs, its safety record in other studies is encouraging. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard antibiotics typically used for urinary tract infections (UTIs), phage therapy uses viruses called bacteriophages that specifically target and destroy bacteria causing these infections. Researchers are excited about this treatment because, unlike antibiotics, phages can evolve alongside bacteria, potentially reducing the chance of resistance developing. Additionally, phages are highly specific, which means they can target harmful bacteria without disrupting beneficial bacteria in the body. This precision and adaptability make phage therapy a promising alternative to traditional antibiotic treatments, especially for patients with spinal cord injuries who may experience recurrent UTIs.

What evidence suggests that phage therapy might be an effective treatment for urinary tract infections in spinal cord injury?

This trial will compare phage therapy with a placebo for treating urinary tract infections (UTIs) in individuals with spinal cord injuries. Research has shown that phage therapy can effectively treat UTIs, even when other treatments fail. Phages are viruses that specifically target and destroy certain bacteria, helping to clear infections. Studies have found positive results with phage therapy, especially against stubborn, drug-resistant bacteria. For people with spinal cord injuries, phages can also break down biofilms, which are slimy layers that protect bacteria, and fight infections. While more research is needed, these early findings suggest phage therapy could be a promising option for treating UTIs in this group. ^{1 2 3 4 6}

Who Is on the Research Team?

Barbara W Trautner, MD, PhD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 with spinal cord injury (SCI) who have neurogenic bladders and E. coli bacteriuria, using catheters for bladder drainage. Participants must consent to study procedures, use two forms of contraception if applicable, and be available for the study duration. Those hospitalized or able to visit the clinic for treatment initiation can join.

Inclusion Criteria

I have a urinary infection with E. coli at a specific level.

I use a catheter regularly for urination.

I have signed and understand the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 30 days

Treatment

Participants receive investigational phage therapy or placebo intravesicularly twice a day for 7 days

7 days

14 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments on Days 14, 21, and 35

35 days

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Phage Therapy

Trial Overview The trial tests a new phage therapy against a placebo in SCI patients with bladder colonization by E. coli. It's designed to check safety and how the body processes the therapy (pharmacokinetics) and responds to it (pharmacodynamics), in a controlled environment where participants are randomly assigned.

How Is the Trial Designed?

Group I: Phage Arm Experimental Treatment 1 Intervention

A sterile solution of one to three individual phages (cocktail) (3 x 10\^8 plaque forming units \[PFU\]) phage(s) will be administered intravesicularly (instilled into the participant's bladder via catheter) twice a day for 7 days. The name of the active treatment IP is TAILФR Phage Cocktail (TPC).

Group II: Placebo Arm Placebo Group 1 Intervention

Sterile 0.9% saline solution will be instilled into the bladder via catheter twice a day for 7 days

Who Is Running the Clinical Trial?

Barbara Wells Trautner

Lead Sponsor

Trials

1

Recruited

30+

Published Research Related to This Trial

Bacteriophage therapy was effective in curing urinary tract infections (UTIs) in rats when administered at higher concentrations (1×10^8 PFU/ml and 1×10^7 PFU/ml).

The lowest concentration (1×10^6 PFU/ml) required more frequent doses to effectively eliminate the bacteria, suggesting that optimizing dosage and frequency is crucial for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bacteriophage therapy for Escherichia coli-induced urinary tract infection in rats. Bhargava, K., Nath, G., Dhameja, N., et al.[2023]

In a study of 136 patients with spinal cord injury, oral immunomodulation therapy using E. coli fractions significantly reduced the frequency of recurrent urinary tract infections (UTIs) from 93.4% to 59.6% over 12 months.

The therapy also increased the proportion of patients reporting no UTIs from 2.2% to 20.6%, indicating its potential as an effective preventive treatment for UTIs in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of oral immunomodulation therapy on urinary tract infections in individuals with chronic spinal cord injury-A retrospective cohort study. Krebs, J., Fleischli, S., Stoyanov, J., et al.[2020]

Phage therapy has shown promise as an alternative treatment for multidrug-resistant infections, with some successful case studies already reported.

This commentary highlights the potential of phage therapy specifically for treating urinary tract infections, suggesting it could be a valuable tool in addressing antibiotic resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phage therapy for urinary tract infections: does it really work? González-Villalobos, E., Molina-López, J., Balcázar, JL.[2022]

In a study involving 21 spinal cord injured patients, the use of E. coli 83972 for bladder colonization was found to be safe, with successful long-term colonization achieved in 13 participants for an average of 12.3 months without any urinary tract infections (UTIs) during that time.

Patients who were successfully colonized reported a significant reduction in the frequency of symptomatic UTIs, going from an average of 3.1 infections per year before colonization to none while colonized, suggesting that E. coli 83972 could be an effective preventive strategy for UTIs in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urinary tract infection prophylaxis using Escherichia coli 83972 in spinal cord injured patients. Hull, R., Rudy, D., Donovan, W., et al.[2007]

In a study involving 90 female albino mice, a phage cocktail was found to effectively clear uropathogenic E. coli from the urinary tract, demonstrating its potential as a treatment for urinary tract infections (UTIs).

The phage cocktail's success is attributed to its broader host range compared to a single phage, which showed no therapeutic effect, highlighting the importance of using a combination of phages for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Phage Cocktail Therapy of the Urinary Tract Infection in a Mouse Model. Mijbel Ali, B., Gatea Kaabi, SA., Al-Bayati, MA., et al.[2023]

The study successfully isolated and characterized two bacteriophages that effectively target local uropathogenic E. coli strains responsible for urinary tract infections, showing promise for phage therapy as a treatment option.

These phages, when combined into a cocktail, demonstrated strong activity against specific E. coli phylogroups (B2 and D), indicating their potential for tailored therapeutic applications in combating antibiotic-resistant infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of Anti-Bacterial Effect of the Two New Phages against Uropathogenic Escherichia coli. Slobodníková, L., Markusková, B., Kajsík, M., et al.[2021]

A newly developed phage cocktail effectively targets and lyses over 80% of contemporary E. coli strains associated with catheter-associated urinary tract infections (CAUTI), demonstrating strong efficacy against both young and mature biofilms.

Combining this phage cocktail with antibiotics not only enhances treatment effectiveness but also helps prevent the development of phage-resistant E. coli, suggesting a promising therapeutic strategy for managing CAUTI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Phage Cocktails to Treat E. coli Catheter-Associated Urinary Tract Infection and Associated Biofilms. Sanchez, BC., Heckmann, ER., Green, SI., et al.[2023]

Bacteriophage therapy showed a high clinical efficacy of 92% and bacteriological efficacy of 84% in treating urinary infections in 46 patients, indicating it is a promising alternative to traditional antibacterial treatments.

Phagotherapy was found to be effective and safe, especially when used alone or in combination with antibiotics, suggesting it could help reduce the issues of antibiotic resistance and dysbacteriosis associated with conventional antibacterial therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The efficacy of bacteriophage preparations in treating inflammatory urologic diseases]. Perepanova, TS., Darbeeva, OS., Kotliarova, GA., et al.[2020]

Phage therapy using HP3 and ES17 against uropathogenic E. coli (UPEC) showed that while resistance can develop quickly in the urinary environment, this resistance comes with fitness costs that may make the bacteria more vulnerable to host immunity and antibiotics.

Phage-resistant UPEC strains exhibited reduced growth in human urine and were less effective at colonizing the bladder in a mouse model, suggesting that phage therapy could be a viable treatment option for UTIs if resistance leads to decreased bacterial fitness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phage Resistance Accompanies Reduced Fitness of Uropathogenic Escherichia coli in the Urinary Environment. Zulk, JJ., Clark, JR., Ottinger, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12356746/

Phage Therapy for Urinary Tract Infections Although there are numerous reports of positive outcomes for UTI patients after phage therapy [48], critical evaluation of these reports is ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06559618

NCT06559618 | Bacteriophage Therapy in Spinal Cord ... This is a Phase 1b study to assess the safety, tolerability, PK, and PD of investigational phage therapy (IP) in adults with SCI and bladder colonization ...

3. nature.com nature.com/articles/s41393-021-00636-2

what role may they play in life after spinal cord injury? The ability of phages to both degrade biofilms and eliminate bacteria represents a great potential for the treatment of skin and bone infections ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/14787210.2025.2513459

Phage therapy in patients with urinary tract infections Phage therapy often served as the sole viable treatment for XDR infections, yielding positive results despite small sample sizes and data heterogeneity.

5. frontierspartnerships.org frontierspartnerships.org/journals/acta-biochimica-polonica/articles/10.3389/abp.2025.14264/full

Phages as potential life-saving therapeutic option in the ... Phage therapy (PT) has emerged as a promising alternative due to its specificity, safety and efficacy against multidrug-resistant (MDR) pathogens causing ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405456919303402

Bacteriophages: a Panacea in Neuro-Urology? Recent clinical studies using bacteriophage therapy for UTIs showed encouraging results. In particular, patients with recurrent UTIs, such as ...