Probiotic
Dietary Supplement1 capsule of probiotic (Lactobacillus CECT 9422 + Bifidobacterium CECT 30257) every 12 hours for 6-months.
NCT Number: NCT05895578
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).
This study is active but is not currently recruiting participants.
Notify Me18 year–65 year
Female
Interventional
Not applicable
Hospital La Moraleja, Madrid, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 capsule of probiotic (Lactobacillus CECT 9422 + Bifidobacterium CECT 30257) every 12 hours for 6-months.
1 capsule of probiotic + 1 capsule of placebo per day for 6-months.
1 capsule of placebo every 12 hours for 6-months.
Time frame: Before intervention
The number of participants with a positive urine culture will be compared between groups of treatment.
Time frame: After 3 months of intervention.
The number of participants with a positive urine culture will be compared between groups of treatment.
Time frame: After 6 months of intervention.
The number of participants with a positive urine culture will be compared between groups of treatment.
Time frame: Before intervention
The total bacterial count in urine samples will be compared between groups of treatment.
Time frame: After 3 months of intervention
The total bacterial count in urine samples will be compared between groups of treatment.
Time frame: After 6 months of intervention
The total bacterial count in urine samples will be compared between groups of treatment.
Time frame: After 3 and 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
The number of participants which associate sexual activity with the apperance of an UTI episode will be counted and compared between groups.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
Time frame: After 6 months of intervention.
The composition of fecal microbiome will be compared between treatments group and time
Time frame: After 6 months of intervention.
The composition of urine microbiota will be compared between treatments group and time.
Time frame: After 6 months of intervention.
ProbiSearch SL
Industry
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).
Acronym: PROBUTI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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