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

NCT06659016 | Completed Phase 4

• 1 other identifier: 10/2024/SCCAL
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infection (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• Number of urinary tract infections per month

  6 and 12 months

Secondary Outcomes (2)

• ICIQ-FLUTS scores

  6 and 12 months

• Number of women matching recurrent urinary tract infection criteria

  12 months

Study Arms (3)

Group A

ACTIVE COMPARATOR

Drug: Fosfomycin 3 g

Group B

EXPERIMENTAL

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.

Dietary Supplement: Uroxin 4G

Group C

EXPERIMENTAL

Combination of treatment A and B

Drug: Combination of dietary supplement and fosfomycin

Interventions

Fosfomycin 3 g DRUG

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.

Group A

Uroxin 4G DIETARY_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.

Group B

Combination of dietary supplement and fosfomycin DRUG

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.

Group C

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead
• pharmaSuisse: collaborator

Study Sites (1)

University of Campania Luigi Vanvitelli

Napoli, 80138, Italy

Location

Related Publications (1)

• Riemma G, Vinci D, La Verde M, Caniglia FM, Scalzone G, Torella M. Adding collagen, propolis plus quercetin, bacillus coagulans, hyaluronic acid and chondroitin sulphate to D-mannose avoids symptoms and prevents recurrence in women with recurrent urinary tract infections: a single-blind randomized controlled trial. Expert Rev Anti Infect Ther. 2025 Jul;23(7):523-530. doi: 10.1080/14787210.2025.2487162. Epub 2025 Apr 3.

  PMID: 40162673 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections; Disease

Interventions

Fosfomycin; alloxantin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blind to treatment arm
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 26, 2024
• Study Start: February 1, 2023
• Primary Completion: February 10, 2024
• Study Completion: September 30, 2024
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

IT (1)