PROBUTI

Description

A clinical trial evaluating a new treatment for patients with complicated urinary tract infections, with the aim of comparing its efficacy and safety to standard antibiotic therapy.

Target

The study aims to investigate the effect of a probiotic strain on the urinary tract microbiota in women with recurrent urinary tract infections. Given that urinary tract infections are one of the most common bacterial infections in women and tend to recur in a significant percentage of patients, the trial seeks to evaluate whether modulating the urinary tract microbiota with a probiotic can help prevent or reduce the recurrence of these infections.

To whom it is addressed

This study is intended for:

• Adult women aged 18 to 55 who have been diagnosed with recurrent urinary tract infections (defined as at least two episodes in the past six months or three in the past 12 months).
• Diagnosed, within the last 7 days, with a new episode of urinary tract infection.

Treatment

Participants are randomly assigned to one of three treatment groups:

• Group I (probiotic):
  They receive two capsules daily containing a combination of probiotic strains (Lactobacillus CECT 9422 and Bifidobacterium CECT 30257) in full doses.
• Group II (probiotic + placebo):
  Participants receive one daily capsule containing a probiotic (the same combination of strains as in Group I, but at a reduced dose) and one placebo capsule.
• Group III (placebo):
  They receive two placebo capsules daily, containing no active ingredient.

What are these treatments?

Probiotic:
This supplement contains beneficial live microorganisms (such as Lactobacillus and Bifidobacterium) that can help balance the microbiota of the urinary tract. The goal is to promote an environment that inhibits the growth of bacteria responsible for urinary tract infections and help prevent their recurrence.

Probiotic + placebo:
In this group, participants receive a combination of one capsule containing a probiotic (in a lower dose than the main group) and another capsule containing no active ingredient (placebo). This allows researchers to evaluate the effect of the probiotic by adjusting the dose and comparing it with other groups.

Placebo:
These are capsules containing no active ingredient and having no therapeutic effect. They are used in clinical trials to compare results and ensure that the observed effects are actually due to the treatment being studied.

Study phases

Initial evaluation (screening):
Medical tests are performed to confirm the diagnosis and ensure that the patient is eligible to participate.

Treatment:
The patient receives the prescribed antibiotic for the duration specified in the study.

Follow-up:
Clinical examinations and tests are performed to assess the progression of the infection and the response to treatment.

Duration of the study

The study will last six and a half months, including six months of product intake.

What is evaluated

• Treatment of the infection.
• Response to antibiotic treatment.
• Safety and side effects.

Possible risks and side effects

Antibiotics can cause:

• Digestive discomfort.
• Allergic reactions.
• Changes in the bacterial flora.

The medical team monitors for any adverse effects during the study.