A Phase 2/3 interventional study of D-Mannose in Urinary Tract Infections, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-02-04.
Sponsored by Washington University School of Medicine · Phase 2/3, Interventional, and Prevention
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.
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.
803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.
This study's enrollment of 61 is below the median of 131 across 560 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For the RCT arms of the study, the following inclusion criteria will apply:
a. women with recurrent UTI
i. Recurrent UTI defined as:
≥ 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:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants in this arm will not use any additional intervention.
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
Incidence of Symptomatic, Culture Proven Urinary Tract Infections
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).
Time frame: each participant will be followed for 90 days during study enrollment
Incidence of Symptomatic Culture Proved UTI From D-mannose Susceptible Uropathogens
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 (Control Arm).
Time frame: each participant will be followed for 90 days during study enrollment
Side Effects
To describe the side effects of D-mannose and determine the incidence of discontinuation of therapy due to side effects.
Time frame: each participant will be followed for 90 days during study enrollment
Incidence of Symptomatic, Culture Proven UTI in All Participants Taking D-mannose
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).
Time frame: each participant will be followed for 90 days during study enrollment
| Milestone | RCT Treatment Arm | RCT Control Arm | Observational Arm |
|---|---|---|---|
| Started | 28 | 29 | 4 |
| Completed | 19 | 25 | 3 |
| Not completed | 9 | 4 | 1 |
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).
| Participants | RCT Treatment Arm | RCT Control Arm | Observational Arm |
|---|---|---|---|
| Incidence of Symptomatic, Culture Proven Urinary Tract Infections | 6 | 12 | 1 |
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 (Control Arm).
| Participants | RCT Treatment Arm | RCT Control Arm | Observational Arm |
|---|---|---|---|
| Incidence of Symptomatic Culture Proved UTI From D-mannose Susceptible Uropathogens | 6 | 10 | 1 |
To describe the side effects of D-mannose and determine the incidence of discontinuation of therapy due to side effects.
| Participants | RCT Treatment Arm | RCT Control Arm | Observational Arm |
|---|---|---|---|
| Side Effects | 3 | 0 | 0 |
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).
| Participants | RCT Treatment Arm | RCT Control Arm | Observational Arm |
|---|---|---|---|
| Incidence of Symptomatic, Culture Proven UTI in All Participants Taking D-mannose | 6 | 12 | 1 |
Collected over Adverse events were collected from dose day 1 through 90 days after treatment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RCT Treatment Arm | 0/27 (0%) | 0/27 (0%) | 14/27 (51.9%) |
| RCT Control Arm | 0/29 (0%) | 0/29 (0%) | 16/29 (55.2%) |
| Observational Arm | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) |
| Event | RCT Treatment Arm | RCT Control Arm | Observational Arm |
|---|---|---|---|
| FlatulenceGastrointestinal disorders | 11/27 | 5/29 | 2/4 |
| DiarrheaGastrointestinal disorders | 4/27 | 6/29 | 0/4 |
| DyspepsiaGastrointestinal disorders | 4/27 | 5/29 | 0/4 |
| Age, Categorical(Participants) | RCT Treatment Arm | RCT Control Arm | Observational Arm | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 13 | 1 | 23 |
| >=65 years | 19 | 16 | 3 | 38 |
| Age, Continuous(years) | RCT Treatment Arm | RCT Control Arm | Observational Arm | Total |
|---|---|---|---|---|
| Mean | 70.7 (53 to 90) | 67.4 (50 to 83) | 71.5 (63 to 79) | 69.2 (50 to 90) |
| Sex: Female, Male(Participants) | RCT Treatment Arm | RCT Control Arm | Observational Arm | Total |
|---|---|---|---|---|
| Female | 28 | 29 | 4 | 61 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | RCT Treatment Arm | RCT Control Arm | Observational Arm | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 0 | 1 |
| Not Hispanic or Latino | 28 | 28 | 4 | 60 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | RCT Treatment Arm | RCT Control Arm | Observational Arm | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 0 | 3 |
| White | 26 | 28 | 4 | 58 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | RCT Treatment Arm | RCT Control Arm | Observational Arm | Total |
|---|---|---|---|---|
| United States | 28 | 29 | 4 | 61 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — There is no plan to share individual participant data
Ran from Mar 2018 to primary completion in Apr 2020, 25 months.
Results were first posted in Feb 2022, 1 year 9 months after primary completion.
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Studies of the drug tested here: Mannose
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