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OpenTrials
Completed

NCT Number: NCT06659016

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

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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Key information

Conditions

Urinary Tract Infection (Diagnosis) Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

21 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Campania Luigi Vanvitelli

Naples, 80138, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Number of urinary tract infections per month

    Time frame: 6 and 12 months

Secondary outcomes

  1. ICIQ-FLUTS scores

    Time frame: 6 and 12 months

  2. Number of women matching recurrent urinary tract infection criteria

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Collaborators

  • pharmaSuisse

Registry information

Official study title

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

Acronym: IMProBaCist-Q

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 26, 2024
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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