Parshottam Koradia1, Shital Kapadia2, Yamini Trivedi3, Gajendrasinh Chanchu4, Ashton Harper5. 1. Dept of Clinical Research, BAPS Pramukh Swami Hospital , Ahmedabad , India. 2. Dept of Obstetrics and Gynecology, B.J. Medical College and Civil Hospital , Ahmedabad , India. 3. Department of Obstetrics & Gynaecology, AMCMET L.G. General Hospital , Ahmedabad , India. 4. Department of Data operations, QED Clinical Services Ind Pvt Limited , Ahmedabad , Gujarat , India. 5. Medical Affairs Department, ADM Protexin Ltd , Somerset , UK.
Abstract
Objectives: To assess efficacy and safety of Bio-Kult Pro-Cyan (BKPro-Cyan), a product containing two strains of Lactobacilli plus cranberry extract, for preventing recurrent UTIs in pre-menopausal adult women. Methods: This was a randomized, double-blind, placebo-controlled pilot study. Subjects received BKPro-Cyan or placebo twice-daily for 26 weeks. The primary endpoint was the proportion of subjects with recurrent UTI at the end of the study. Results:115 subjects were screened; 90 were enrolled; 81 completed the study. After 26 weeks, a significantly lower number of women experienced recurrent UTIs with BKPro-Cyan compared to placebo (9.1 vs 33.3%; P = 0.0053). BKPro-Cyan produced statistically significant improvements compared to placebo for multiple secondary endpoints, including: greater number of subjects who experienced no UTIs (90 vs 67%; P < 0.05); longer time to first UTI (174 vs 90 days; P = 0.001); shorter duration of active UTI (5 vs 12 days; P = 0.009); Fewer subjects requiring antibiotics (3 vs 11; P < 0.05); and shorter median duration of antibiotic treatment (4 vs 7 days; P = 0.09).Conclusions: BKPro-Cyan was safe and effective for preventing recurrent UTI in pre-menopausal adult women. These findings support the need for further well-designed trials to clarify the benefits that may be achieved.
RCT Entities:
Objectives: To assess efficacy and safety of Bio-Kult Pro-Cyan (BKPro-Cyan), a product containing two strains of Lactobacilli plus cranberry extract, for preventing recurrent UTIs in pre-menopausal adult women. Methods: This was a randomized, double-blind, placebo-controlled pilot study. Subjects received BKPro-Cyan or placebo twice-daily for 26 weeks. The primary endpoint was the proportion of subjects with recurrent UTI at the end of the study. Results: 115 subjects were screened; 90 were enrolled; 81 completed the study. After 26 weeks, a significantly lower number of women experienced recurrent UTIs with BKPro-Cyan compared to placebo (9.1 vs 33.3%; P = 0.0053). BKPro-Cyan produced statistically significant improvements compared to placebo for multiple secondary endpoints, including: greater number of subjects who experienced no UTIs (90 vs 67%; P < 0.05); longer time to first UTI (174 vs 90 days; P = 0.001); shorter duration of active UTI (5 vs 12 days; P = 0.009); Fewer subjects requiring antibiotics (3 vs 11; P < 0.05); and shorter median duration of antibiotic treatment (4 vs 7 days; P = 0.09).Conclusions: BKPro-Cyan was safe and effective for preventing recurrent UTI in pre-menopausal adult women. These findings support the need for further well-designed trials to clarify the benefits that may be achieved.
Authors: Virginia Perez-Carrasco; Ana Soriano-Lerma; Miguel Soriano; José Gutiérrez-Fernández; Jose A Garcia-Salcedo Journal: Front Cell Infect Microbiol Date: 2021-05-18 Impact factor: 5.293
Authors: Paul Loubet; Jérémy Ranfaing; Aurélien Dinh; Catherine Dunyach-Remy; Louis Bernard; Franck Bruyère; Jean-Philippe Lavigne; Albert Sotto Journal: Front Microbiol Date: 2020-07-03 Impact factor: 5.640
Authors: T Schiereck; S Yeldan; J Kranz; L Schneidewind; F Wagenlehner; I Wieters; M J G T Vehreschild; T Otto; D Barski Journal: Urologe A Date: 2021-08-23 Impact factor: 0.639