Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection. (PROBUTI)

ProbiSearch

Status: Enrolling

Conditions: Recurrent Urinary Tract Infection

Treatments: Dietary Supplement: Probiotic + placebo; Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05895578

UTI/23.01

Details and patient eligibility

About

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).

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Menopausal
• Pregnant, breastfeeding or planning to become pregnant during the study.
• Congenital abnormalities of the urinary tract.
• Renal functional alterations, such as neurogenic bladder or vesicoureteral reflux.
• Relevant renal disorders, such as interstitial cystitis, renal lithiasis, renal failure, kidney transplantation, pyelonephritis, renal nephropathy, etc.
• Permanent catheter.
• Immunocompromised (eg: cancer and/or transplant, patients who are taking immunosuppressive drugs, patients with hereditary diseases that affect or may affect the immune system).
• Type I diabetes.
• With a defect in the intestinal epithelium barrier (eg: chronic diarrhea, inflammatory bowel disease).
• Heart failure and cardiac medical history (eg, artificial heart valve, medical history of infective endocarditis, rheumatic fever, or cardiac malformation).
• Under antibiotics prophylactic treatment without willingness to leave it at the time of inclusion.
• Probiotics supplementation during the previous 2 weeks.
• To have received Urovac, Uro-Vaxom or equivalent vaccine during the last year.
• Currently participating in another clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups, including a placebo group

Probiotic

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Probiotic

Probiotic + placebo

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Probiotic + placebo

Placebo

Placebo Comparator group

Description:

Two capsules daily of Placebo supplement.

Treatment:

Dietary Supplement: Placebo