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 (IMProBaCist-Q)

University of Campania "Luigi Vanvitelli"

Status and phase: Completed; Phase 4

Conditions: Urinary Tract Infection (Diagnosis)

Treatments: Drug: Fosfomycin 3 g; Drug: Combination of dietary supplement and fosfomycin; Dietary Supplement: Uroxin 4G

Study type: Interventional

Funder types: Other

Identifiers

NCT06659016

10/2024/SCCAL

Details and patient eligibility

About

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.

Enrollment: 148 patients

Sex: Female

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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148 participants in 3 patient groups

Group A

Active Comparator group

Treatment:

Drug: Fosfomycin 3 g

Group B

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Uroxin 4G

Group C

Experimental group

Description:

Combination of treatment A and B

Treatment:

Drug: Combination of dietary supplement and fosfomycin