Ramona-Alexandra CIAUŞU, Tudor ILIE, Alin Stelian CIOBICĂ, Bogdan NOVAC
ABSTRACT :
Background: Urinary tract infections (UTIs) are among the most common bacterial infections globally, with Escherichia coli accounting for roughly 70-90% of community-acquired cases. The rise in antibiotic resistance in uropathogenic E. coli (UPEC), particularly strains that produce extended-spectrum beta-lactamase (ESBL), presents a substantial treatment challenge. In preclinical trials, essential oils (EOs) displayed antibacterial, antibiofilm, and synergistic efficacy with conventional antibiotics. However, clinical evidence for oral EOs supplementation as an adjuvant therapy in UTIs is minimal. Objective: To assess the feasibility, safety, and preliminary clinical effects of oral essential-oil supplementation combined with routine antibiotic therapy in patients with drug-resistant E. coli UTIs. Materials and methods: This is a single-center, randomized, controlled pilot trial with 40-60 adult participants who have culture-confirmed drugresistant E. coli UTIs. Participants will be randomly assigned to receive either standard antibiotic therapy alone or antibiotic therapy combined with N-BIOT1C PROSINERGIC, a standardized oral essential-oil supplement for 14 days. The primary results are feasibility metrics and safety. Secondary exploratory outcomes are clinical resolution, time to symptom alleviation, antibiotic duration, and 30-day recurrence. Conclusions: This pilot study will provide feasibility and safety data to help build a bigger definitive randomized controlled trial. Keywords: antibiotic, escherichia coli, urinary tract infections.