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

NCT04880343 | Suspended

• 1 other identifier: FJD-URO-19-001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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)

Conditions

Lower Urinary Tract Infection

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Number of symptomatic UTIs

  Variable for each participant over course of up to one year

Study Arms (3)

Group (C)

NO INTERVENTION

Control

Group (A)

EXPERIMENTAL

Treatment

Dietary Supplement: Group (A)

Group (B)

EXPERIMENTAL

Treatment

Dietary Supplement: Group (B)

Interventions

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 (A)

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

Group (B)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Not based on self-representation
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carmen Gonzalez Enguita: lead

Study Sites (1)

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 10, 2021
• Study Start: January 26, 2021
• Primary Completion: January 26, 2024
• Study Completion: January 26, 2024
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)