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Nutraceutical Efficacy for rUTI

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ClinicalTrials.gov Identifier: NCT03395288
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Drug: D-Mannose Phase 2 Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There will be a RCT portion of the study with a treatment arm and a control arm and an additional observational arm of the study.
Masking: Single (Participant)
Masking Description: Participants in the RCT treatment and RCT control arm will not be told the name of the nutraceutical being studied. Participants in the observational arm will be aware of the nutraceutical being studied.
Primary Purpose: Prevention
Official Title: Randomized, Controlled Trial to Determine the Efficacy of Nutraceutical vs Control as Non-antibiotic Prophylaxis for Recurrent Urinary Tract Infection in Postmenopausal Women Using Vaginal Estrogen Therapy
Actual Study Start Date : March 22, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RCT treatment arm
Participants in this arm will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days.
Drug: D-Mannose
A total of 2 g D-mannose daily

No Intervention: RCT control arm
Participants in this arm will not use any additional intervention.
Experimental: Observational arm
Participants in this arm will either take a total of 1000 mg D-mannose in capsule form every 12 hours OR they will dissolve one (1) level teaspoon of the nutraceutical powder (D-mannose) in at least 200 ml of water one time a day, approximately every 24 hours. (200 ml of water = 6.7 fluid ounces). Duration of study drug is 90 days. Participants in this arm of the study have different home medications prior to study enrollment than participants in the RCT treatment arm.
Drug: D-Mannose
A total of 2 g D-mannose daily




Primary Outcome Measures :
  1. incidence of symptomatic, culture proven urinary tract infections [ Time Frame: each participant will be followed for 90 days during study enrollment ]
    To compare the cumulative incidence of symptomatic, culture-proven urinary tract infections in postmenopausal women with a history of rUTI on vaginal estrogen therapy randomized to receive prophylactic D-mannose versus women using vaginal estrogen therapy alone (control).


Secondary Outcome Measures :
  1. incidence of symptomatic culture proved UTI from D-mannose susceptible uropathogens [ Time Frame: each participant will be followed for 90 days during study enrollment ]
    To compare the incidence of symptomatic, culture-proven urinary tract infections caused by all uropathogens potentially susceptible to D-mannose therapy in women receiving D-mannose and the control group. We will also compare these findings to the incidence of symptomatic, culture-proven urinary tract infections caused by uropathogens susceptible to D-mannose therapy in the absence of vaginal estrogen therapy (observational arm).

  2. side effects [ Time Frame: each participant will be followed for 90 days during study enrollment ]
    To describe the side effects of D-mannose and determine the incidence of discontinuation of therapy due to side effects.

  3. incidence of symptomatic, culture proven UTI in all participants taking D-mannose [ Time Frame: each participant will be followed for 90 days during study enrollment ]
    To compare the cumulative incidence of symptomatic, culture-proven urinary tract infections between women receiving prophylactic D-mannose treatment alongside vaginal estrogen therapy verses women receiving prophylactic D-mannose treatment whom are not on vaginal estrogen therapy (observational arm).

  4. design of future studies [ Time Frame: exit survey at completion of each participant's 90 days of enrollment in the study ]
    To gain information to use in designing future rUTI studies



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   This study will involve only adult, postmenopausal women as recurrent UTI predominantly affect this population. Recurrent UTI in men would be considered complicated and would not be addressed with a prophylactic treatment like d-mannose.In addition, men do not go through menopause and do not have a vagina and would thus not be treated with vaginal estrogen therapy.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For the RCT arms of the study, the following inclusion criteria will apply:

a. Postmenopausal women with recurrent UTI

i. Recurrent UTI defined as:

  1. ≥ 2 symptomatic, culture-proven UTI in 6 months OR
  2. ≥ 3 symptomatic, culture-proven UTI in 12 months

    ii. Postmenopausal defined as no menses for at least 12 months or surgical menopause

    b. At least one documented prior uropathogen susceptible to D-mannose

    c. Using VET for a minimum of four weeks prior to study day 1

    Inclusion criteria for the Observational arm of the study are the same with the exception of item 'c.' above (using VET for a minimum of four weeks) as participants will not be on vaginal estrogen therapy.

    Exclusion Criteria:

    For the RCT arms of the study, the exclusion criteria are as follows:

    1. Not postmenopausal
    2. Currently on daily antibiotic UTI prophylaxis (If this is the only exclusion criteria met, a woman could be cleared for inclusion in study/enrollment after a 2 week washout period occurs prior to inclusion in the study (RCT or Observational arm))
    3. Complicated UTIs (known renal tract anomaly, inability to empty bladder due to neurologic causes, performs self-catheterization or has an indwelling catheter)
    4. Patients with incomplete bladder emptying (defined as post void residual > 150 cc when minimal voided volume is >150 cc)
    5. Known contraindication to VET unless approved by patient's oncologist, oncologic surgeon, or primary care physician (History of or current endometrial cancer; History of estrogen sensitive breast cancer without approval of patient, patient's oncologist, oncologic surgeon, or primary care physician to use vaginal estrogen after counseling)
    6. History of interstitial cystitis/painful bladder syndrome
    7. Urothelial cancer
    8. Non-English speaking
    9. Enrolled in other clinical trials for UTIs
    10. Currently using D-mannose or Methenamine for UTI prevention

    Exclusion criteria for the Observational arm of the study are the same with the exception of item 'e.' above (known contraindication to VET) as participants will not be on vaginal estrogen therapy.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395288


Contacts
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Contact: Stacy Lenger 314-747-1402 slenger@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: administrative assistant    314-747-1402      
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Stacy Lenger, MD Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03395288     History of Changes
Other Study ID Numbers: 201711120
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:
UTI
recurrent UTI

Additional relevant MeSH terms:
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Infection
Urinary Tract Infections
Urologic Diseases