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 — Phase 4, Completed, 148 participants, University of Campania Luigi Vanvitelli

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

EFFICACIA DI UN INTEGRATORE A BASE DI D-MANNOSIO, PROPOLI, QUERCETINA, COLLAGENE E BACILLUS COAGULANS NEL RIDURRE L'INCIDENZA E MIGLIORARE LA QUALITA' DI VITA IN DONNE CON CISTITE RICORRENTE

Registry	NCT06659016, acronym IMProBaCist-Q
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	148 (Actual)
Sponsor	University of Campania Luigi Vanvitelli (Other); collaborators: pharmaSuisse
Conditions	Urinary Tract Infection (Diagnosis)
Interventions	Fosfomycin 3 g, Uroxin 4G, Combination of dietary supplement and fosfomycin (Drug, dietary supplement)
Dates	start 2023-02-01, primary completion 2024-02-10, completion 2024-09-30, first posted 2024-10-26, last updated 2024-10-26
Locations	1 site in Italy

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Group A	Active comparator	Drug: Fosfomycin 3 g
Group B	Experimental	Dietary Supplement: 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	Experimental	Drug: Combination of dietary supplement and fosfomycin	Combination of treatment A and B

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.
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.
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.

+Outcome measures

Primary outcomes

Number of urinary tract infections per month [6 and 12 months]

Secondary outcomes

ICIQ-FLUTS scores [6 and 12 months]
Number of women matching recurrent urinary tract infection criteria [12 months]

+Eligibility

Sex: Female, ages: 21 Years to 65 Years

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.

+Locations (1)

Facility	City	Country	Status
University of Campania Luigi Vanvitelli	Naples	Italy

+Publications

Results publication: 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