Lower Urinary Tract InfectionNCT04880343
Clinical Study to Evaluate the Efficacy of the Dietary Supplement UROMANNOSA® in Women With Recurrent Lower Urinary Tract Infections
A study testing Group (A) and Group (B) in people with Lower Urinary Tract Infection, run by Carmen Gonzalez Enguita at 1 site in Spain.
Trial summary
To analyze the clinical impact of a food supplement composed of D Mannose, cranberry extract (Cran-max) and Vitamin D3 in the prevention of recurrent lower urinary tract infections (UTI) Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Lower Urinary Tract Infection
- What is being tested?
- Group (A) and Group (B)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- 26 Jan 2021to 26 Jan 2024
- Phase
- Interventional
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of Recurrent Lower Urinary Tract Infection (at least two episodes in the last 6 months or three episodes in the last 12 months).
- Multiple infections must be spaced a minimum of 2 weeks apart or if less, with a negative urine culture in between.
- Women who agree to participate and give their informed consent in writing
Who cannot join
- Use of antibiotics or cranberry or other preventive treatment, pharmacological or not, for recurrence of urinary tract infections in the last two weeks.
- Patient with indwelling catheter or intermittent catheterization.
- Patients who present: Interstitial Cystitis, Neurogenic Bladder, Diabetes Mellitus, Nephrolithiasis, Cervical-Uterine Cancer diagnosed and treated less than 5 years ago.
- Use of anticoagulants or contraceptive methods using spermicides or diaphragms.
- Women consuming probiotics or foods, beverages or supplements containing extracts or parts of the genus Vaccinum sp, including other forms of V. macrocarpon (blueberry), V. myrtillus (European blueberry), V.angustifolium (wild or lowbush blueberry), V. corymbosum ( highbush blueberry) or V. vitis-ideae (mountain blueberry), during the two weeks prior to recruitment.
- High consumption of fruits rich in phenolic compounds, with special reference to berries.
- Women allergic to berries
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Open-label, Controlled Clinical Trial to Evaluate the Efficacy of a Product Consisting of D Mannose 2 g+ Cran-max 500 mg+ Vitamin D3 0.001 mg (UROMANNOSA®) in Women With Recurrent Lower Urinary Tract Infections
To analyze the clinical impact of a food supplement composed of D Mannose, cranberry extract (Cran-max) and Vitamin D3 in the prevention of recurrent lower urinary tract infections (UTI)
Read the detailed description
Once patients have been informed about the study, the potential risks and treatment alternatives, those who meet the selection criteria, agree to participate and sign the informed consent, will be randomly and openly assigned, in a 1:1:1 ratio, to one of the following groups:
Group A: Patients with repeat UTIs who will receive prophylactic treatment for 6 Months.
Group B: Patients with repeat UTIs who will receive prophylactic treatment for 3 Months.
Control group: Patients with recurrent UTIs who will not receive as prophylactic treatment the supplement under study.
The three groups will be treated following standard clinical practice with follow-up at 3, 6, 9 and 12 months after inclusion.
- Conditions
- Lower Urinary Tract Infection
- Being tested
- Group (A), Group (B)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group (A)Dietary supplement
Group that will take a daily dose of the commercial dietary supplement provided by the sponsor, composed of mannose, cran-max and vitamin D for 6 months
Group (B)Dietary supplement
Group that will take a daily dose of the commercial dietary supplement provided by the sponsor, composed of mannose, cran-max and vitamin D for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Group (C) | No intervention | Control |
| Group (A) | Experimental | Treatment Receives: Dietary Supplement: Group (A) |
| Group (B) | Experimental | Treatment Receives: Dietary Supplement: Group (B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
UTI Recurrence
Number of patients with recurrences (defined as: number of patients with at least one UTI during the study period) at 6 months.
Measured: Through study completion, an average of one year
UTI Recurrence
Time (in days) from the start of treatment to the next episode of UTI
Measured: Variable for each participant over course of up to one year
Number of symptomatic UTIs
Measured: Variable for each participant over course of up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start26 Jan 2021
- Primary completion26 Jan 2024 (estimated)
- Study completion26 Jan 2024 (estimated)
Why it stopped: Difficulties in recruiting the control arm in accordance with the protocol prevent the study population from being reached.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract InfectionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmen Gonzalez Enguita
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carmen Gonzalez Enguita, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880343
- Sponsor's protocol ID
- FJD-URO-19-001
- Status last verified
- Sep 2023
- First submitted
- 29 Apr 2021
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Open-label, Controlled Clinical Trial to Evaluate the Efficacy of a Product Consisting of D Mannose 2 g+ Cran-max 500 mg+ Vitamin D3 0.001 mg (UROMANNOSA®) in Women With Recurrent Lower Urinary Tract Infections
- ClinicalTrials.gov ID
- NCT04880343
- Acronym / sponsor ID
- FJD-URO-19-001
- Conditions
- Lower Urinary Tract Infection
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Difficulties in recruiting the control arm in accordance with the protocol prevent the study population from being reached.
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Carmen Gonzalez EnguitaUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 26 Jan 2024 (estimated)
- Study completion
- 26 Jan 2024 (estimated)
- First posted
- 10 May 2021 (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.
To analyze the clinical impact of a food supplement composed of D Mannose, cranberry extract (Cran-max) and Vitamin D3 in the prevention of recurrent lower urinary tract infections (UTI)
Detailed description
Once patients have been informed about the study, the potential risks and treatment alternatives, those who meet the selection criteria, agree to participate and sign the informed consent, will be randomly and openly assigned, in a 1:1:1 ratio, to one of the following groups:
Group A: Patients with repeat UTIs who will receive prophylactic treatment for 6 Months.
Group B: Patients with repeat UTIs who will receive prophylactic treatment for 3 Months.
Control group: Patients with recurrent UTIs who will not receive as prophylactic treatment the supplement under study.
The three groups will be treated following standard clinical practice with follow-up at 3, 6, 9 and 12 months after inclusion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (C) | No intervention | –Control |
| Group (A) | Experimental | Dietary Supplement: Group (A)Treatment |
| Group (B) | Experimental | Dietary Supplement: Group (B)Treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of Recurrent Lower Urinary Tract Infection (at least two episodes in the last 6 months or three episodes in the last 12 months).
- Multiple infections must be spaced a minimum of 2 weeks apart or if less, with a negative urine culture in between.
- Women who agree to participate and give their informed consent in writing
Key exclusion criteria (8 listed)
- Use of antibiotics or cranberry or other preventive treatment, pharmacological or not, for recurrence of urinary tract infections in the last two weeks.
- Patient with indwelling catheter or intermittent catheterization.
- Patients who present: Interstitial Cystitis, Neurogenic Bladder, Diabetes Mellitus, Nephrolithiasis, Cervical-Uterine Cancer diagnosed and treated less than 5 years ago.
- Use of anticoagulants or contraceptive methods using spermicides or diaphragms.
- Women consuming probiotics or foods, beverages or supplements containing extracts or parts of the genus Vaccinum sp, including other forms of V. macrocarpon (blueberry), V. myrtillus (European blueberry), V.angustifolium (wild or lowbush blueberry), V. corymbosum ( highbush blueberry) or V. vitis-ideae (mountain blueberry), during the two weeks prior to recruitment.
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 |
|---|---|---|
| Group (A)Group that will take a daily dose of the commercial dietary supplement provided by the sponsor, composed of mannose, cran-max and vitamin D for 6 months | Dietary supplement | Group (A) |
| Group (B)Group that will take a daily dose of the commercial dietary supplement provided by the sponsor, composed of mannose, cran-max and vitamin D for 3 months | Dietary supplement | Group (B) |
Primary outcome
UTI Recurrence
Time frame: Through study completion, an average of one year
Number of patients with recurrences (defined as: number of patients with at least one UTI during the study period) at 6 months.
UTI Recurrence
Time frame: Variable for each participant over course of up to one year
Time (in days) from the start of treatment to the next episode of UTI
Number of symptomatic UTIs
Time frame: Variable for each participant over course of up to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
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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 study testing Group (A) and Group (B) in people with Lower Urinary Tract Infection, run by Carmen Gonzalez Enguita at 1 site in Spain.
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 3 inclusion and 8 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: paused, as of the sponsor's last update on 29 Sep 2023. 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 Spain. 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.
Are results available for this study?
Results are not available in the source record.
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?
UTI Recurrence (time frame: Through study completion, an average of one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2023.