Ignite Creation Date:
2024-05-06 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03597152
Status:
UNKNOWN
Last Update Posted:
2020-01-10
First Post:
2018-07-13
Brief Title:
Nutritional Supplementation for Recurrent Urinary Tract Infections in Women
Sponsor:
AmPurity Nutraceuticals LLC
Organization:
AmPurity Nutraceuticals LLC
Study Overview
Official Title:
Nutritional Supplementation for Extending Time Between Recurrent Urinary Tract Infections in Women a Randomized Double Blind Cross-over Trial
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will test the ability of specially formulated nutritional supplement capsules to extend the time between recurrent urinary tract infections in women This objective will be completed by enrolling women who have suffered from 3-4 uncomplicated UTIs in the past 12 months into a double blind placebo controlled cross-over trial Cross-over and study completion are triggered by the next two UTI recurrences The goal of the study is for the supplement to extend the time to the next UTI for study participants as compared to placebo
Detailed Description:
Background Recurrent urinary tract infections UTIs ie having three or more infections in 12 months present a common and serious health problem for women Long-term prophylactic antibiotic use is one treatment approach though there are currently no consensus treatment strategies for chronic recurrent UTIs which makes development of antibiotic resistant bacterial strains a major concern Alternatively nutritional supplements such as those based on cranberry and the sugar d-mannose have shown some mixed success as a complementary treatment for UTIs Thus identification of a multi-ingredient nutritional supplement which could reduce the recurrence of UTIs when applied in conjunction with standard of care would be valuable to the heath and healthcare of women
Objective The study will test the efficacy of a twice-daily nutritional supplement for extending the time between recurrent UTIs in women The supplement is a commercially available product WelTract AmPurity LLC whose capsules contain extracts from Hibiscus flowers and cranberry fruit lactoferrin D-mannose and vitamins C and D
Methods The study design will be a randomized double-blind placebo-controlled cross-over trial The primary outcome will be time to recurrence of next UTI Women age 18-75 yrs will be enrolled at a private urology clinic upon presentation of their 3rd or 4th simple cystitis of the lower urinary tract in the past 12 months Randomization and product consumption will occur concurrently with standard of care treatment acute antibiotics of the infection Resolution of the infection will be confirmed by urine culture and supplement or placebo consumption will continue until UTI recurrence which will trigger cross-over Again standard of care will ensue and consumption of the supplement or placebo will continue until UTI recurrence which triggers participant study completion Cross-over is not forced and the maximum allowable time to cross-over andor complete the study is one year per participant Side-effects will be monitored and reported
Analysis Plan The study plans to enroll a maximum of 250 women intending to ensure that 150 women complete the study Statistical analysis will be performed using both the non-parametric Log Rank test and the Gail and Simon method each with different primary outputs statistical significance and effect size respectively Both of these methods are suitable for comparing paired time-to-event measures as found in a cross-over design The baseline sample size N150 was calculated using the Cox Proportional Hazard method at 85 desired power an alpha level 005 a representative hazard ratio of 07 from prior cranberry treatment trials and allowing for up to 40 of the subjects to not complete the study due to reasons such as withdrawal or dropout
Clinical Significance The daily consumption of a scientifically-based multi-ingredient nutritional supplement may provide a safe and practical means to extend the time until recurrence of the next UTI for women who have suffered 3-4 UTIs in the past 12 months when applied in combination with standard of care
Objective The study will test the efficacy of a twice-daily nutritional supplement for extending the time between recurrent UTIs in women The supplement is a commercially available product WelTract AmPurity LLC whose capsules contain extracts from Hibiscus flowers and cranberry fruit lactoferrin D-mannose and vitamins C and D
Methods The study design will be a randomized double-blind placebo-controlled cross-over trial The primary outcome will be time to recurrence of next UTI Women age 18-75 yrs will be enrolled at a private urology clinic upon presentation of their 3rd or 4th simple cystitis of the lower urinary tract in the past 12 months Randomization and product consumption will occur concurrently with standard of care treatment acute antibiotics of the infection Resolution of the infection will be confirmed by urine culture and supplement or placebo consumption will continue until UTI recurrence which will trigger cross-over Again standard of care will ensue and consumption of the supplement or placebo will continue until UTI recurrence which triggers participant study completion Cross-over is not forced and the maximum allowable time to cross-over andor complete the study is one year per participant Side-effects will be monitored and reported
Analysis Plan The study plans to enroll a maximum of 250 women intending to ensure that 150 women complete the study Statistical analysis will be performed using both the non-parametric Log Rank test and the Gail and Simon method each with different primary outputs statistical significance and effect size respectively Both of these methods are suitable for comparing paired time-to-event measures as found in a cross-over design The baseline sample size N150 was calculated using the Cox Proportional Hazard method at 85 desired power an alpha level 005 a representative hazard ratio of 07 from prior cranberry treatment trials and allowing for up to 40 of the subjects to not complete the study due to reasons such as withdrawal or dropout
Clinical Significance The daily consumption of a scientifically-based multi-ingredient nutritional supplement may provide a safe and practical means to extend the time until recurrence of the next UTI for women who have suffered 3-4 UTIs in the past 12 months when applied in combination with standard of care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None