Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of a Probiotic on the Urinary Tract Microbiota in Women With Recurrent Urinary Tract Infections (rUTI).

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Urinary tract infections (UTIs) are the most common bacterial infections in women. 50% of women experiencing at least one UTI in their lifetime with an annual prevalence of 0.5-0.7%. An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic strains on the urinary tract microbiota in participants with recurrent urinary tract infection (rUTI). The study duration will be 6 and a half months, including 6 months product intake. Participants will be randomly assigned to one of the three study groups: control group with placebo administration, probiotic administration group (1 dose) and probiotic administration group (2 doses).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• Adult women with aged between 18 and 55 years old, diagnosed with recurrent UTI (defined as at least two episodes during the last six months or three during the last 12 months).

• Diagnosed, the last 7days, for a new UTI episode.

• Written informed consent signed.

Locations
Other Locations
Spain
Hospital La Moraleja
RECRUITING
Madrid
Hospital La Zarzuela
RECRUITING
Madrid
Hospital San Francisco de Asís
RECRUITING
Madrid
Contact Information
Primary
Susana Manzano Jiménez, PhD
susana.manzano@probisearch.com
918035179
Time Frame
Start Date: 2023-06-21
Estimated Completion Date: 2026-03
Participants
Target number of participants: 90
Treatments
Active_comparator: Probiotic
2 Capsule daily containing approximately 1\*10E9 colony forming unit (CFU) of Lactobacillus CECT 9422 +1\*10E9 colony forming unit (CFU) of Bifidobacterium CECT 30257.
Active_comparator: Probiotic + placebo
One capsule daily containing approximately 1\*10E9 colony forming unit (CFU) of Lactobacillus CECT 9422 +1\*10E9 colony forming unit (CFU) of Bifidobacterium CECT 30257 and 1 capsule of placebo supplement.
Placebo_comparator: Placebo
Two capsules daily of Placebo supplement.
Related Therapeutic Areas
Sponsors
Leads: ProbiSearch SL

This content was sourced from clinicaltrials.gov