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

NCT ID: NCT06659016

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-09-30

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group A

Group Type: ACTIVE_COMPARATOR

Fosfomycin 3 g

Intervention Type: 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 B

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 Type: EXPERIMENTAL

Uroxin 4G

Intervention Type: 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 C

Combination of treatment A and B

Group Type: EXPERIMENTAL

Combination of dietary supplement and fosfomycin

Intervention Type: 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.

Interventions

Fosfomycin 3 g

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.

Intervention Type: DRUG

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.

Intervention Type: DIETARY_SUPPLEMENT

Combination of dietary supplement and fosfomycin

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

pharmaSuisse

UNKNOWN

Sponsor Role: collaborator

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role: lead

Responsible Party

Gaetano Riemma

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Campania Luigi Vanvitelli

Napoli, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 40162673 (View on PubMed)

Other Identifiers

10/2024/SCCAL

Identifier Type: -

Identifier Source: org_study_id