NCT03019172

Clinical Trial of L. Reuteri in Urinary Tract Infections in Non Pregnant Women

Safety, and Effectiveness of Lactobacillus Reuteri for the Treatment of Urinary Tract Infections in Women: A Pilot Randomized Clinical Trial (RCT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Innovacion y Desarrollo de Estrategias en Salud · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 16666 \& Lactobacillus reuteri DSM 17938 to significantly modify the frequency of clinical or bacteriological cure in women with non complicated acute cystitis who receive probiotics for 12 days compared with the frequency in women who receive placebo.

Detailed description

Randomized, double blind, placebo controlled, pilot trial to evaluate the safety and efficacy of L. reuteri in non menopausal women with non complicated cystitis in terms of the frequency of clinical or bacteriological cure. Secondary outcomes will be a) time to clinical/laboratory relapse in at least 70% of women with non complicated acute cystitis who receive probiotics for 12 days compared with the time in women who receive placebo; b) frequency of clinical/laboratory and bacteriologic relapse in women with non complicated acute cystitis who receive probiotics for 12 days compared with the frequency in women who receive placebo, at day 30 after treatment start and c) frequency of adverse related events in women with non complicated acute cystitis who receive probiotics for 12 days compared with the frequency in women who receive placebo. In the active product we will use 5\*10\^8 CFU of Lactobacillus reuteri DSM 16666 \& Lactobacillus reuteri DSM 17938 + cranberry extract. The control group will recibe Cranberry extract. The products will be taken twice per day, morning and evening.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Lactobacillus reuteri	Sachet one contains a total of 5\*10\^8 CFU of Lactobacillus reuteri DSM 16666 \& Lactobacillus reuteri DSM 17938, mixed with maltodextrin for flowability during production. Sachet two contains instant cranberry drink composed of Cranberry extract, xylitol, cranberry aroma, monosodium citrate, zink gluconate, silica. The products will be taken twice per day, morning and evening. The daily dose in the active group will be at least 5\*10\^8 CFU of L.reuteri DSM16666 and L. reuteri DSM17938), PAC-A and zinc
DIETARY_SUPPLEMENT	Sachet with cranberry + placebo	Sachet one contains placebo for probiotics (maltodextrin). Sachet two contains instant cranberry drink composed of Cranberry extract, xylitol, cranberry aroma, monosodium citrate, zink gluconate, silica.

Timeline

• Start date: 2017-03-05
• Primary completion: 2017-07-30
• Completion: 2017-09-30
• First posted: 2017-01-12
• Last updated: 2017-11-29

Locations

1 site across 1 country: Mexico