Actively Recruiting
Study Comparing OM-89 Capsules to Placebo for Reducing Antibiotic Use in Urinary Tract Infections Among Patients with Neurogenic Bladder Using Clean Intermittent Catheterization
Led by Centre Hospitalier Universitaire Dijon · Updated on 2026-03-17
110
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Recurrent urinary tract infections (UTIs) are a major issue for patients with neurogenic bladder who use clean intermittent catheterization (CIC). These infections are the leading cause of sickness and the second leading cause of death in this group. Multidrug-resistant bacteria are common due to frequent antibiotic use and hospital stays. Preventing UTIs with treatments other than antibiotics is important to reduce antibiotic exposure and resistance. The study focuses on evaluating an immunoactive bacterial lysate called OM-89, which has shown promise in reducing UTIs and antibiotic use but needs confirmation in high-risk patients with neurogenic bladder following spinal cord injury. Participants will receive OM-89 or a placebo in two phases. In the first phase, they will take one capsule daily for 90 days, followed by 90 days without treatment, then one capsule daily for 10 days each month for three months. In the crossover phase, those who initially received placebo will then take OM-89 with the same dosing schedule. This approach aims to assess the effectiveness of OM-89 in preventing UTIs and reducing antibiotic use. During the study, researchers will monitor the number of antibiotic treatments needed for UTIs over 12 months. Participants will undergo regular urine cultures, urodynamic examinations, and tracking of antibiotic consumption. Safety, bacterial resistance, and effects on urinary and digestive microbiota will also be evaluated. Participants will keep daily diaries and be followed up via telephone. The total duration covers at least one year to capture infection recurrence and treatment impact.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Person who has given written consent
- Patient aged 18 years or older
- Patient with a stabilised neurogenic bladder following spinal cord injury that has not progressed for more than 2 years and who has undergone a urodynamic examination in the last 2 years
- Patients using clean intermittent catheterization (5 to 6 times per day)
- Patients who have received at least 6 courses of antibiotic treatment for UTIs in the 12 months prior to screening
- Patients with a negative urine culture between screening visit and randomisation or treated with antibiotics for urinary decontamination prior to randomisation
You will not qualify if you...
- Person who is not affiliated with the national health insurance system
- Person subject to a measure of legal protection (guardianship, tutorship)
- Person subject to a court order
- Adults unable to express consent
- Patients using a urinary drainage method other than clean intermittent catheterization
- Patients with urinary lithiasis at the time of inclusion
- Presence of an endo-urinary device (urinary prosthesis, ureteral stent)
- Enterocystoplasty or irradiated bladder (past or present)
- Known allergy or previous intolerance to OM-89 or placebo components
- Patient requiring ongoing or short-term prolonged antibiotic therapy
- Patient treated with bacterial lysates in the 6 months prior to randomisation
- Unable or unwilling to stop prophylactic antibiotic therapy prior to randomisation
- Patient with a known malignant tumour or neoplasia
- Patient with an autoimmune disease
- Patient treated with long-term or bolus corticosteroids, anti-CD20 or anti-rejection therapy in the 6 months prior to screening
- Patient currently in another study related to urinary tract infections or treated with investigational treatment within 30 days prior to screening
- Patient unable to collect information in a daily diary
- Patient unable to understand follow-up by telephone
- Patients planning to move to another residence within one year after randomisation
- Non-menopausal women who are not surgically sterile and who are pregnant, breast-feeding, planning to conceive, or not using effective contraception
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Trial Site Locations
Total: 1 location
1
CHU Dijon Bourgogne
Dijon, France, 21000
Actively Recruiting
Research Team
L
Lionel PIROTH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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