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

Lower Urinary Tract Infection Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04880343
• Other study ID #: FJD-URO-19-001
• Status: Suspended
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: January 26, 2024

Study information

• Verified date: September 2023
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 108
• Est. completion date: January 26, 2024
• Est. primary completion date: January 26, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Lower Urinary Tract Infection
• Urinary Tract Infections

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Carmen Gonzalez Enguita

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UTI Recurrence	Number of patients with recurrences (defined as: number of patients with at least one UTI during the study period) at 6 months.	Through study completion, an average of one year
Primary	UTI Recurrence	Time (in days) from the start of treatment to the next episode of UTI	Variable for each participant over course of up to one year
Primary	Number of symptomatic UTIs		Variable for each participant over course of up to one year