Multicentre Randomised Double-blind Superiority Trial to Assess the Efficacy of OM-89 vs Placebo in Reducing Antibiotic Use for Urinary Tract Infections in Patients With Neurogenic Bladder

What this Trial Is About

Recurrent urinary tract infections (UTIs) are a significant problem for patients with a neurogenic bladder who use clean intermittent catheterization (CIC). These infections are a leading cause of illness and death in this group, often involving multidrug-resistant bacteria due to frequent antibiotic use and hospital stays. Preventing UTIs without relying on antibiotics is important to reduce antibiotic exposure and resistance, and bacterial lysates like the Escherichia Coli extract (OM-89) have shown promise as a preventative option in high-risk patients. This trial compares OM-89 to a placebo in patients with neurogenic bladder to evaluate its effect on reducing antibiotic use for UTIs. Participants receive either one capsule daily of OM-89 or placebo for 90 days, followed by 90 days without treatment, then one capsule daily for 10 days each month over three months. Those initially on placebo will later receive OM-89 in a roll-over phase with the same dosing schedule. Participants will be monitored for one year, with researchers tracking the number of antibiotic treatments for UTIs. The study includes assessments such as urine cultures, daily diaries, and follow-up calls to evaluate infection frequency, antibiotic consumption, bacterial resistance, and urinary and digestive microbiota. The trial aims to provide high-quality evidence on OM-89's role in preventing recurrent UTIs and reducing antibiotic use in this vulnerable population.

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