Clinical Study to Evaluate the Efficacy of the Dietary Su... | NCT04880343

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

NCT04880343

Sponsor

Carmen Gonzalez Enguita

Status

Suspended

Last Update Posted

Sep 29, 2023Actual

Enrollment

108Estimated

Phase

Not Applicable

Conditions

Lower Urinary Tract Infection

Interventions

Group (A)
Group (B)

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulties in recruiting the control arm in accordance with the protocol prevent the study population from being reached.

Expanded Access Info

Start Date

Jan 26, 2021Actual

Primary Completion Date

Jan 26, 2024Estimated

Completion Date

Jan 26, 2024Estimated

First Submitted Date

Apr 29, 2021

First Submission Date that Met QC Criteria

May 5, 2021

First Posted Date

May 10, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2023

Last Update Posted Date

Sep 29, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

108Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group (C)	No Intervention	Control
Group (A)	Experimental	Treatment	Dietary Supplement: Group (A)
Group (B)	Experimental	Treatment	Dietary Supplement: Group (B)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not based on self-representation

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario Fundación Jiménez Díaz		Madrid		28040	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003710	Demography
D011154	Population Characteristics