Assess the Efficacy of OM-89 vs Placebo in Reducing Antibiotic Consumption Associated With the Treatment of Urinary Tract Infections in Patients With Neurogenic Bladder
This study is looking for people who have a condition called neurogenic bladder, which is often linked to spinal cord injuries, and frequently get urinary tract infections (UTIs). UTIs are a big problem for these individuals, often leading to a lot of antibiotic use, which can make bacteria harder to treat. Doctors want to see if a special capsule called OM-89, which is not an antibiotic, can help prevent UTIs and reduce the need for antibiotics. Participants will take either the OM-89 capsule or a dummy capsule (placebo) to see which is more effective. The aim is to find better ways to prevent UTIs and cut down on antibiotic use in this group.
At a glance
What is this study about?
If you have a neurogenic bladder, especially after a spinal cord injury, you might know that getting frequent urinary tract infections (UTIs) can be a real struggle. These infections are not only uncomfortable but also often need antibiotics to clear up. Using antibiotics too often can unfortunately make bacteria stronger and harder to treat in the future. This study wants to find a better way to tackle this problem.
The researchers are testing a special capsule called OM-89. This capsule isn't an antibiotic; instead, it's designed to help your body's immune system fight off infections. Think of it as a way to gently train your body to be better at defending itself against the germs that cause UTIs. They want to see if taking this capsule regularly can lead to fewer UTIs and, importantly, reduce how often people need to take antibiotics.
This study is really important because if OM-89 works, it could offer a new option for people like you to stay healthier and use fewer antibiotics. This means potentially fewer trips to the doctor, less discomfort, and a better way to manage your health long-term.
Key takeaways
- New study for people with neurogenic bladder and frequent UTIs.
- Aims to check if OM-89 capsules reduce UTIs and antibiotic use.
- Compares OM-89 to a dummy capsule (placebo).
- Hopes to find better non-antibiotic prevention for UTIs.
- Participation involves taking daily capsules and regular check-ups.
- Your health and safety are the top priority; you can leave anytime.
Who may be eligible?
This study is looking for adult volunteers, aged 18 or over. You'd need to have a stable neurogenic bladder linked to a spinal cord injury, and you must consistently use a method called clean intermittent catheterisation (CIC) about 5 to 6 times a day. A key part of joining is having had at least six courses of antibiotics for UTIs in the last year, and your urine test needs to be clear before you start the study medication.
There are also some reasons why you wouldn't be able to join. For example, if you have certain other serious health conditions like cancer or an autoimmune disease, or if you're taking specific long-term medications that affect your immune system. You also can't be in the study if you have a known allergy to the study medication, are using another type of urinary drainage, or have had certain bladder surgeries or conditions. It's important to discuss all your health conditions and medications with the study team to see if this study is right for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a stable neurogenic bladder due to a spinal cord injury?
- Do you use clean intermittent catheterisation (CIC) daily?
- Have you had at least 6 antibiotic courses for UTIs in the last 12 months?
- Are you able to provide written permission (consent) to join the study?
What does participation involve?
If you join this study, you'll be randomly assigned to take either the OM-89 capsule or a dummy capsule (placebo) every day for a set period. Neither you nor the study team will know which capsule you are taking. You'll have regular visits to the clinic where the team will monitor your health, ask about any UTIs, and collect urine samples. They will also keep track of any antibiotics you take. There might be some questionnaires to fill out too. The total duration of your involvement, including follow-up, will be explained in detail by the study team, but it will involve consistent capsule-taking and scheduled appointments.
Potential risks and benefits
Locations (1)
- CHU Dijon BourgogneVerified postcodeDijon, France· Recruiting
Common questions
What is a 'neurogenic bladder'?
It means your bladder doesn't work quite right because of nerve problems, often due to a spinal cord injury. This can make it hard to empty your bladder properly.
What is 'clean intermittent catheterisation' (CIC)?
It's a way to regularly empty your bladder using a small tube (catheter) yourself, to help prevent infections and keep your bladder healthy.
What is OM-89?
It's a special capsule, not an antibiotic, designed to help boost your body's natural defences against urinary tract infections.
What is a 'placebo'?
A placebo is a dummy capsule that looks exactly like the study medicine but doesn't contain any active ingredients. It helps us compare the real effect of the treatment.
Will I know if I'm getting the real medicine or the placebo?
No, during the study, neither you nor the doctors will know who is receiving OM-89 and who is receiving the placebo. This is to ensure fair and accurate results.
How to find out more
Lionel PIROTH
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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