NCT04880343

Clinical Study to Evaluate the Efficacy of the Dietary Supplement UROMANNOSA® in Women With Recurrent Lower Urinary Tract Infections

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Carmen Gonzalez Enguita · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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 (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

Timeline

• Start date: 2021-01-26
• Primary completion: 2024-01-26
• Completion: 2024-01-26
• First posted: 2021-05-10
• Last updated: 2023-09-29

Locations

1 site across 1 country: Spain