In short
A clinical trial is underway to evaluate the effectiveness of E. coli Polysaccharide (OM-89) in reducing antibiotic consumption for patients with neurogenic bladder and recurrent urinary tract infections (UTIs). This study aims to compare the use of OM-89 against a placebo in patients with spinal cord injuries, focusing on antibiotic use, UTI incidence, hospitalization rates, and quality of life over a two-year period.
At a glance
- Study Type
- Randomized, double-blind, placebo-controlled trial
- Intervention
- E. coli Polysaccharide (OM-89) vs Placebo
- Primary Outcome
- Number of antibiotic treatment episodes for UTIs per person-days at risk during the first year
- Key Secondary Outcomes
- UTI incidence, hospitalization rates, antibiotic use, quality of life
- Duration
- 2 years
- Key Inclusion Criteria
- Adults with stabilized neurogenic bladder, using CIC, history of recurrent UTIs
- Key Exclusion Criteria
- Other urinary drainage methods, urinary lithiasis, endo-urinary devices, autoimmune diseases
What is E. Coli Polysaccharide (OM-89)?
E. Coli Polysaccharide, also known as OM-89 or by its brand name Uro-Vaxom, is a medication classified as a bacterial vaccine. It is derived from components of E. coli bacteria and is used to help prevent recurrent urinary tract infections (UTIs). This medication is part of a group called "bacterial lysates," which are products made from broken-down bacterial cells.
Medical Conditions Treated
E. Coli Polysaccharide is primarily used to treat two related conditions:
- Recurrent urinary tract infections (UTIs): These are infections that keep coming back, affecting the urinary system.
- Neurogenic bladder: This is a condition where a person lacks bladder control due to brain, spinal cord, or nerve problems.
These conditions often occur together in patients with spinal cord injuries, making them more susceptible to frequent UTIs.
How It Works
E. Coli Polysaccharide works by stimulating the body's immune system. By introducing harmless parts of E. coli bacteria (which commonly cause UTIs) into the body, it helps train the immune system to recognize and fight off these bacteria more effectively when a real infection occurs. This can potentially reduce the frequency and severity of UTIs, especially in people who get them often.
Potential Benefits
The main goal of using E. Coli Polysaccharide is to reduce the need for antibiotics in treating UTIs. Potential benefits include:
- Fewer episodes of UTIs
- Reduced use of antibiotics, which can help prevent antibiotic resistance
- Fewer hospitalizations due to UTIs or related complications
- Improved quality of life for patients with recurrent UTIs
Administration
E. Coli Polysaccharide (Uro-Vaxom) is typically given as a hard capsule for oral use. The usual dose is 6 mg per day, with a maximum daily dose of 6 mg. The treatment can last up to 240 days (about 8 months), with a maximum total dose of 1400 mg over this period.
Who Can Use This Treatment?
This treatment is generally considered for adults (18 years or older) who have:
- A stabilized neurogenic bladder due to spinal cord injury for more than 2 years
- Frequent UTIs (at least 6 episodes requiring antibiotics in the past 12 months)
- Use of clean intermittent catheterization (CIC) 5-6 times per day (CIC is a method where patients insert a clean catheter into their bladder to drain urine, then remove it)
However, this treatment may not be suitable for everyone. People with certain conditions, such as active cancer, autoimmune diseases, or those taking specific medications, may not be eligible.
Ongoing Research
A clinical trial called RETRAIN is currently underway to further evaluate the effectiveness of E. Coli Polysaccharide (OM-89) compared to a placebo. This study aims to:
- Compare the rate of antibiotic use for UTIs between patients taking OM-89 and those taking a placebo
- Assess the impact on the frequency of UTIs over a two-year period
- Evaluate the effect on hospitalization rates due to UTIs
- Measure changes in patients' quality of life
Safety and Side Effects
While E. Coli Polysaccharide is generally considered safe, like all medications, it can have side effects. The ongoing clinical trial is closely monitoring for any adverse events, ranging from mild to severe. It's important to discuss potential risks and benefits with your healthcare provider before starting this or any new treatment.
Remember, this information is based on current research and may change as more studies are completed. Always consult with your healthcare provider for the most up-to-date and personalized medical advice.