Nutraceutical Efficacy for rUTI

Status Terminated

Clinical Trial Summary

This is a study designed to evaluate the efficacy of a nutraceutical as a non-antibiotic treatment to prevent recurrent urinary tract infections in women that have completed menopause and are on vaginal estrogen therapy. An additional group of women with recurrent urinary tract infections that have completed menopause but are not using vaginal estrogen therapy will be followed while taking the nutraceutical. The study length is ninety days from the date that the study participant will be instructed is day 1.

Clinical Trial Description

The objective of this study is to determine the efficacy of a nutraceutical as a non-antibiotic prophylaxis for postmenopausal women on vaginal estrogen therapy (VET) with a history of symptomatic, culture-proven recurrent urinary tract infection (rUTI) by means of a randomized, controlled trial. Recurrent urinary tract infections have a significant impact on patient health, quality of life, and finances (personal and societal). The most common uropathogen for both acute and recurrent UTIs is Escherichia coli. Historically, patients with rUTI have been placed on long-term prophylactic antibiotics to prevent recurrence. Long term antibiotic use can lead to antibiotic resistance, collateral damage to normal flora, and organ damage, such as pulmonary and hepatic toxicity with long-term nitrofurantoin use. There is an increasing prevalence of antibiotic resistance of uropathogenic E. coli and other uropathogens. Antibiotic resistance and its consequences have resulted in a need for non-antibiotic prophylaxis regimens. A growing body of literature supports the use of vaginal estrogen therapy as a first-line non-antibiotic UTI prevention strategy in postmenopausal women. While VET has been shown to significantly reduce the risk of rUTIs, some women continue to have rUTIs. Other non-antibiotic strategies have been utilized including D-mannose, a nutraceutical. Three prior studies examined D-mannose as an isolated therapy with promising results, but in our experience, a multimodal approach has often been needed. Therefore, additional studies, such as this proposed research, are needed to determine the potential additive effect of a nutraceutical as a non-antibiotic prophylaxis for postmenopausal women using vaginal estrogen therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03395288
Study type	Interventional
Source	Washington University School of Medicine
Contact
Status	Terminated
Phase	Phase 2/Phase 3
Start date	March 22, 2018
Completion date	April 25, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04495699` - Asymptomatic Renal Calculi in Recurrent Urinary Tract Infections
Terminated	`NCT05254808` - EXtended Use of FOsfomycin for the Treatment of CYstitis in Primary Care	Phase 3
Completed	`NCT03680612` - Cefepime/AAI101 Phase 2 Study in Hospitalized Adults With cUTI	Phase 2
Completed	`NCT03282006` - Treating Pyelonephritis an Urosepsis With Pivmecillinam	Phase 4
Completed	`NCT03526484` - The Utility of Urinalysis Prior to In-Office Procedures	N/A
Completed	`NCT05397782` - Effects of Flourish on Recurrent Urinary Tract Infection	N/A
Completed	`NCT05018546` - Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery	N/A
Completed	`NCT03687255` - Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections	Phase 3
Recruiting	`NCT05227937` - Single Dose Amikacin for Uncomplicated Cystitis in the ED: A Feasibility Study
Completed	`NCT02864420` - Hospitalization at Home: The Acute Care Home Hospital Program for Adults	N/A
Completed	`NCT03131609` - Avoiding Bacterial Contamination of Clean Catch Urine Cultures in Ambulatory Patients in the Emergency Department
Completed	`NCT01911143` - A Retrospective, Blinded Validation of a Host-response Based Diagnostics	N/A
Completed	`NCT01333254` - A Trial of Different Methods for Bladder Drainage in Hip Surgery Patients	N/A
Terminated	`NCT00594594` - Adjuntive Probiotic Therapy in Treating Urinary Tract Infections in Spinal Cord Injury	Phase 1
Completed	`NCT00216853` - A Study of Vaginal MicroFlora and Immune Profiles of Patients With Recurrent Urinary Tract Infection	N/A
Completed	`NCT00787085` - The Significance of Funguria in Hospitalized Patients	N/A
Completed	`NCT05719753` - The Effectiveness of a Bacteriophobic Coating on Urinary Catheters	N/A
Recruiting	`NCT05415865` - The Effect of Local Anesthetic Solution in the Bladder Prior to Botox Injections in the Bladder	Phase 3
Not yet recruiting	`NCT05880329` - DIagnoSing Care hOme UTI Study
Recruiting	`NCT04615065` - Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.