Efficacy of Collagen, Propolis Plus Quercetin (Proqutin®), Bacillus Coagulans, Hyaluronic Acid and Chondroitin Sulphate and D-Mannose to Avoid Symptoms and Prevents Recurrence in Women With Recurrent Urinary Tract Infections

University of Campania Luigi Vanvitelli148 enrolled

Overview

The aim of this study is to evaluate whether a dietary supplement based on D-mannose, collagen, hyaluronic acid, chondroitin sulphate, enhanced by the properties of quercetin plus propolis (Proqutin ®) and Bacillus Coagulans, eventually associated with antimicrobial prophylaxis, could be effective in preventing recurrent UTIs and improving related quality of life.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

148

Conditions

Urinary Tract Infection (Diagnosis)

Interventions

Fosfomycin 3 gDRUG

Uroxin 4GDIETARY_SUPPLEMENT

Dietary supplement of D-mannose, collagen, hyaluronic acid, chondroitin sulphate, propolis plus quercetin (Proqutin ®) and Bacillus Coagulans (Uroxin 4G, Pharmasuisse laboratories, Milan, Italy) administered twice daily for seven days in the first month, then once daily for 14 days a month for two months, repeated every three months for a total treatment duration of 12 months.

Combination of dietary supplement and fosfomycinDRUG

Fosfomycin trometamol 3 g administered orally in a single dose every ten days for three months, repeated every three months for a total treatment duration of 12 months, combined with an oral formulation of D-mannose, collagen, hyaluronic acid, chondroitin sulphate, propolis plus quercetin (Proqutin ®) and Bacillus Coagulans (Uroxin 4G, Pharmasuisse laboratories, Milan, Italy) administered twice daily for seven days in the first month, then once daily for 14 days a month for two months, repeated every three months for a total treatment duration of 12 months.

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * a history of rUTIs (defined by EAU guidelines as a frequency of at least three UTIs per year, or two UTIs in the past six months in the last 12 months, confirmed by positive urine cultures * not undergone any previous treatment for their condition. Exclusion Criteria: * age under or over limit * concurrent antimicrobial treatment * any ongoing treatment that could influence study outcomes, * congenital or post-surgical urinary tract anomalies * immunodeficiency or HIV infection * ongoing pregnancy.

Outcomes

Primary Outcomes

Number of urinary tract infections per month

Time frame: 6 and 12 months

Secondary Outcomes

ICIQ-FLUTS scores