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

NCT ID: NCT04880343

Last Updated: 2023-09-29

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-26
• Study Completion Date: 2024-01-26

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.

Conditions

Lower Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group (C)

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group (A)

Treatment

Group Type: EXPERIMENTAL

Group (A)

Intervention Type: 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 (B)

Treatment

Group Type: EXPERIMENTAL

Group (B)

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Carmen Gonzalez Enguita

OTHER

Sponsor Role: lead

Responsible Party

Carmen Gonzalez Enguita

Staff Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hospital Universitario Fundación Jiménez Díaz

Madrid, , Spain

Countries

Spain

Other Identifiers

FJD-URO-19-001

Identifier Type: -

Identifier Source: org_study_id