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

Not Applicable

Suspended

• Conditions: Lower Urinary Tract Infection
• Interventions: Dietary Supplement: Group (A); Dietary Supplement: Group (B)

• Registration Number: NCT04880343
• Lead Sponsor: Carmen Gonzalez Enguita

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 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 Timeline

• Study Start: 2021-01-26
• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-10
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-29
• Primary Completion: 2024-01-26
• Study Completion: 2024-01-26

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (A)	Group (A)	Treatment
Group (B)	Group (B)	Treatment

Primary Outcome Measures

Name	Time	Method
Number of symptomatic UTIs	Variable for each participant over course of up to one year
UTI Recurrence	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

Trial Locations

Locations (1)

Hospital Universitario Fundación Jiménez Díaz; 🇪🇸 Madrid, Spain