Funded by Petrovax, a manufacturer that sells PharmaLinea's product under the brand name Uronext, the study concluded that the addition of the supplement to antibiotic treatment resulted in over four times lower chance of relapse and 20% higher improvement in quality of life.
"This study has shown that the [Uronext] food supplement taken daily, every alternating week, for three months is an effective and safe option in addressing patients with [lower urinary tract infections]," researchers from the Basis of Botkin Hospital and Moscow Department of Health in Russia wrote in the journal EC Gynaecology.
UTIs affect around 400 million people yearly, and about 50% of women suffer from UTIs at least once in their lifetime. The main method of treatment is antibiotics, which are both damaging to the microbiome and fail to prevent relapse.
“The market is full of cranberry juices, teas and commodity-based supplements that are of questionable quality and do not have clinical proof of efficacy," said Maja Orešnik, science and research director at PharmaLinea. "Doctors and pharmacists lack options they could confidently prescribe to avoid chronic urinary tract issues and chronic antibiotic use. This market gap led us to develop the Your UTI Free Sachets in the first place and, most recently, to clinically confirm the product’s efficacy.”
Efficacy in treatment and prevention
The study included 98 female patients between the ages of 18 and 80 years with active acute cystitis, which was confirmed by a positive bacteriological urine test. The participants were randomized into two groups and both groups received standard antibiotic therapy, while the study group additionally received the Your UTI Free Sachets.
The trial lasted 12 weeks and aimed to measure the frequency of disease relapses and assess quality of life improvements.
The resulting data revealed the frequency of relapses in the study group was more than four times lower when compared to the control group, and the recurrence rate in the study group was 3.7 times lower than in the control group.
While the median number of recurrences per person in the control group was one, the infection did not recur at all in the majority of the study group. The study group also reported a 20% higher improvement in quality of life during the first week of supplementation when compared to the control group.
Synergistic mechanisms of action
The UTI product studied is a combination of PharmaLinea’s proprietary whole-fruit cranberry ingredient Qcran, a clinically relevant dose of D-mannose and microencapsulated vitamin D3, designed to synergistically prevent bacterial colonization and strengthen the body’s natural defense mechanisms.
Orešnik explained that the unique selling proposition of the patented Qcran ingredient is its production process which aims to ensure high quality, high actives level and a distinctive protection mechanism.
“It is one of the few if not only cranberry ingredient that is 100% whole fruit, without any sort of extraction taking place," she explained. "There are no binders, fillers, spray drying agents or additives. The key advantage is a unique low-temperature production process. The resulting whole fruit product retains all the beneficial properties of cranberries, including 36 mg of the active ingredient PAC per dose and a very high fiber content.
“The fiber content of Qcran is higher than any other cranberry ingredient we’ve tested and especially higher than juices and extracts that represent the majority of the market. We know that fibers are resistant to digestion so the higher fiber content may protect the active ingredient PAC and ultimately lead to higher efficacy."
PACs, the active component of cranberries, are known to bind to receptors on E. coli, thus reducing the possibility of adhering to the bladder or urinary tract, allowing for natural flushing of the bacteria during urination.
D-mannose, a traditional herbal ingredient, is backed by extensive body of clinical data supporting its ability to prevent recurrent infections. It does so by inhibiting E. coli from binding to the walls of uroepithelial cells to prevent colonization.
Vitamin D3 works through the induction of an endogenous antimicrobial peptide in the bladder so recurrent UTIs are associated with vitamin D deficiency.
Source: EC Gynaecology
13.2 (2024): 01-13.
"Prospective Study on the Efficacy and Safety of Uronext® in Parallel Groups in Women with Acute Cystitis"
Authors: Khodyreva L.A. et al.