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

Phase 4

Completed

• Conditions: Urinary Tract Infection (Diagnosis)
• Interventions: Drug: Fosfomycin 3 g; Dietary Supplement: Uroxin 4G; Drug: Combination of dietary supplement and fosfomycin

• Registration Number: NCT06659016
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Primary Completion: 2024-02-10
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-23
• Last Update Submitted: 2024-10-23
• Study First Posted: 2024-10-26
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 148

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Fosfomycin 3 g	-
Group B	Uroxin 4G	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.
Group C	Combination of dietary supplement and fosfomycin	Combination of treatment A and B

Primary Outcome Measures

Name	Time	Method
Number of urinary tract infections per month	6 and 12 months

Secondary Outcome Measures

Name	Time	Method
ICIQ-FLUTS scores	6 and 12 months
Number of women matching recurrent urinary tract infection criteria	12 months

Trial Locations

Locations (1)

University of Campania Luigi Vanvitelli; 🇮🇹 Napoli, Italy