Status:
SUSPENDED
Clinical Study to Evaluate the Efficacy of the Dietary Supplement UROMANNOSA® in Women With Recurrent Lower Urinary Tract Infections
Lead Sponsor:
Carmen Gonzalez Enguita
Conditions:
Lower Urinary Tract Infection
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief 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)
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 ran...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 26 2024
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04880343
Start Date
January 26 2021
End Date
January 26 2024
Last Update
September 29 2023
Active Locations (1)
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1
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040