Urinary Tract Infection (Diagnosis)Phase 4IMProBaCist-QNCT06659016
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
A Phase 4 study testing Fosfomycin 3 g, Uroxin 4G and Combination of dietary supplement and fosfomycin in people with Urinary Tract Infection (Diagnosis), run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Urinary Tract Infection (Diagnosis)
- What is being tested?
- Fosfomycin 3 g, Uroxin 4G and Combination of dietary supplement and fosfomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2023to 30 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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)
- Being tested
- Fosfomycin 3 g, Uroxin 4G, Combination of dietary supplement and fosfomycin
- Medical subject headings
- Urinary Tract Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosfomycin 3 gDrug
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 4GDietary 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 fosfomycinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Not described Receives: 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. Receives: Dietary Supplement: Uroxin 4G |
| Group C | Experimental | Combination of treatment A and B Receives: Drug: Combination of dietary supplement and fosfomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of urinary tract infections per month
Measured: 6 and 12 months
Secondary outcomes (2)
ICIQ-FLUTS scores
Measured: 6 and 12 months
Number of women matching recurrent urinary tract infection criteria
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 Feb 2023
- Primary completion10 Feb 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract Infection (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Collaborators
- pharmaSuisse
- Responsible party
- Principal investigator, Gaetano Riemma, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659016
- Sponsor's protocol ID
- 10/2024/SCCAL
- Acronym
- IMProBaCist-Q
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40162673
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06659016
- Acronym / sponsor ID
- IMProBaCist-Q / 10/2024/SCCAL
- Conditions
- Urinary Tract Infection (Diagnosis)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Collaborators
- pharmaSuisse
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 10 Feb 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Fosfomycin 3 g |
| Group B | Experimental | Dietary Supplement: Uroxin 4GDietary 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 fosfomycinCombination of treatment A and B |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fosfomycin 3 gFosfomycin 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. | Drug | Group A |
| Uroxin 4GDietary 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 | Group B |
| Combination of dietary supplement and fosfomycinFosfomycin 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. | Drug | Group C |
Primary outcome
Number of urinary tract infections per month
Time frame: 6 and 12 months
2 secondary outcomes
ICIQ-FLUTS scores
Time frame: 6 and 12 months
Number of women matching recurrent urinary tract infection criteria
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Derived from this study: PubMed 40162673Riemma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fosfomycin 3 g, Uroxin 4G and Combination of dietary supplement and fosfomycin in people with Urinary Tract Infection (Diagnosis), run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of urinary tract infections per month (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06659016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.