Could a bacterial extract slash antibiotic use in High-Risk bladder patients?
NCT ID NCT06588010
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This study tests whether a daily pill made from bacterial proteins (OM-89) can reduce the number of antibiotics needed for urinary tract infections in adults with neurogenic bladder who use catheters. About 110 participants will receive either OM-89 or a placebo for one year. The goal is to see if this approach lowers infection-related antibiotic use and helps fight antibiotic resistance.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Person who has given written consent * Patient aged 18 years or older * Patient with a stabilised neurogenic bladder following spinal cord injury thaht has not progressed for more than 2 years and who has undergone a urodynamic examination in the last 2 years. * Patients using CIC (5 to 6 per day) * Patients who have received at least 6 courses of antibiotic treatment for UTIs in the 12 months prior to screening (whether for curative or prophylactic reasons) * Patients with a negative urine culture between screening visit and randomisation or treated with antibiotics for urinary decontamination prior to randomisation. Exclusion Criteria: * 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 CIC * Patients with urinary lithiasis at the time of inclusion (assessed by renal imaging in the previous year as part of routine management for patients with a history(s) of lithiasis or within 3 years for patients with no history) * Presence of an endo-urinary device (urinary prosthesis, ureteral stent) * Enterocystoplasty or irradiated bladder (past or present) * Known allergy or previous intolerance to the active substance or one of the excipients of OM-89 or placebo * Patient requiring ongoing or short-term prolonged antibiotic therapy (e.g. infected bedsore, etc.) * Patient treated with bacterial lysates (including OM-89) 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 and anti-rejection therapy in the 6 months prior to screening * Patient currently taking part in another study on an investigational device or drug related to urinary tract infections, or who has received another investigational treatment in the 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 in the year following randomisation * Non-menopausal women who are not surgically sterile (bilateral oophorectomy or hysterectomy) AND pregnant, breast-feeding who are declare that they are planning to conceive at inclusion, or not using effective\* contraception.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU Dijon Bourgogne
RECRUITINGDijon, 21000, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New catheter design aims to make Self-Catheterization easier and more comfortable
- Shockingly simple: wearable zaps aim to end bladder leaks for paralyzed men
- Bladder wash could cut infections and hospital visits for catheter users
- Decades of data: does this bladder surgery stand the test of time for spinal cord injury?
- New registry tracks Real-Life catheter experiences to improve bladder care
- Antibiotics after bladder botox may cut infection risk