Back to resultsClinical Study to Evaluate the Efficacy of the Dietary Supplement UROMANNOSA® in Women With Recurrent Lower Urinary Tract Infections
Primary Purpose
Lower Urinary Tract Infection
Status
Suspended
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Group (A)
Group (B)
Sponsored by
About this trial
This is an interventional prevention trial for Lower Urinary Tract Infection
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.
Sites / Locations
- Hospital Universitario Fundación Jiménez Díaz
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Group (C)
Group (A)
Group (B)
Arm Description
Control
Treatment
Treatment
Outcomes
Primary Outcome Measures
UTI Recurrence
Number of patients with recurrences (defined as: number of patients with at least one UTI during the study period) at 6 months.
UTI Recurrence
Time (in days) from the start of treatment to the next episode of UTI
Number of symptomatic UTIs
Secondary Outcome Measures
Full Information
NCT ID
NCT04880343
First Posted
April 29, 2021
Last Updated
September 27, 2023
Sponsor
Carmen Gonzalez Enguita
1. Study Identification
Unique Protocol Identification Number
NCT04880343
Brief Title
Clinical Study to Evaluate the Efficacy of the Dietary Supplement UROMANNOSA® in Women With Recurrent Lower Urinary Tract Infections
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Suspended
Why Stopped
Difficulties in recruiting the control arm in accordance with the protocol prevent the study population from being reached.
Study Start Date
January 26, 2021 (Actual)
Primary Completion Date
January 26, 2024 (Anticipated)
Study Completion Date
January 26, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carmen Gonzalez Enguita
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group (C)
Arm Type
No Intervention
Arm Description
Control
Arm Title
Group (A)
Arm Type
Experimental
Arm Description
Treatment
Arm Title
Group (B)
Arm Type
Experimental
Arm Description
Treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Group (A)
Intervention Description
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
Intervention Name(s)
Group (B)
Intervention Description
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
Primary Outcome Measure Information:
Title
UTI Recurrence
Description
Number of patients with recurrences (defined as: number of patients with at least one UTI during the study period) at 6 months.
Time Frame
Through study completion, an average of one year
Title
UTI Recurrence
Description
Time (in days) from the start of treatment to the next episode of UTI
Time Frame
Variable for each participant over course of up to one year
Title
Number of symptomatic UTIs
Time Frame
Variable for each participant over course of up to one year
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Not based on self-representation
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hospital Universitario Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study to Evaluate the Efficacy of the Dietary Supplement UROMANNOSA® in Women With Recurrent Lower Urinary Tract Infections
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