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| Name | Class |
|---|---|
| Biofortis Clinical Research, Inc. | INDUSTRY |
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The purpose of this study is to compare the effects of a cranberry juice beverage on rates of Urinary tract infection (UTI) recurrence in women with a history of UTI.
Urinary tract infections (UTI) are the second most common infection of any organ system and the most common urological disease in the United States, with a total annual cost of more than $3.5 billion. Although UTIs can occur in both men and women, they are about 50 times more common in adult women than adult men. It is estimated that 25% of women diagnosed with a primary UTI will suffer a recurrence within two to three months. While no universal definition has been accepted, recurrent UTI is usually defined as three episodes in the last 12 months or two episodes in the last six months following initial infection. In an estimated 75 to 95% of cases of uncomplicated UTI, Escherichia coli (E. coli) is the underlying cause.
Cranberries have historically been associated with urinary tract health, but only recently has the biologic plausibility of cranberry use in the prevention of UTI been addressed. Current research suggests that A-type proanthocyanidins, a specific class of polyphenolic compounds found uniquely abundant in cranberries, inhibit adhesion of bacteria (including multidrug resistant E.coli) to cultured epithelial cells of the urinary tract.
This study will compare the effects of a cranberry juice beverage vs placebo on rates of UTI recurrence in women with a history of UTI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cranberry juice | Active Comparator | cranberry juice beverage at a dose of one 8 oz. beverage per day for six months |
|
| Placebo | Placebo Comparator | placebo beverage at a dose of one 8 oz. beverage per day for six months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cranberry juice | Other | cranberry juice beverage at a dose of one 8 oz. beverage per day for six months |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome variable will be UTI incidence density, defined as the semi-annualized number of UTIs in each group, adjusted for susceptible time under observation. | six months |
| Measure | Description | Time Frame |
|---|---|---|
| Time from randomization to first clinical UTI. Time from randomization to first clinical UTI w/ pyuria. Time from randomization to first clinical UTI w/ microbiological verification. The fraction of subjects w/ one or more episode(s) of clinical UTI. | six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Maki, PhD | Biofortis Clinical Research, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chandler | Arizona | 85224 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37947276 | Derived | Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7. | |
| 37068952 | Derived | Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6. |
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| placebo beverage | Other | placebo beverage at a dose of one 8 oz. beverage per day for six months |
|
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| San Diego | California | 92123 | United States |
| Santa Rosa | California | 95405 | United States |
| Denver | Colorado | 80239 | United States |
| Edgewater | Florida | 32123 | United States |
| Miami | Florida | 33155 | United States |
| Summerfield | Florida | 34491 | United States |
| Ocean Spray Cranberries Research Sites | Addison | Illinois | 60101 | United States |
| Evanston | Illinois | 60201 | United States |
| Edina | Minnesota | 55435 | United States |
| Cincinnati | Ohio | 45249 | United States |
| Columbus | Ohio | 43212 | United States |
| Anderson | South Carolina | 29621 | United States |
| Dallas | Texas | 75231 | United States |
| Pleasant Grove | Utah | 84062 | United States |
| Salt Lake City | Utah | 84124 | United States |
| 33596852 | Derived | Straub TJ, Chou WC, Manson AL, Schreiber HL 4th, Walker BJ, Desjardins CA, Chapman SB, Kaspar KL, Kahsai OJ, Traylor E, Dodson KW, Hullar MAJ, Hultgren SJ, Khoo C, Earl AM. Limited effects of long-term daily cranberry consumption on the gut microbiome in a placebo-controlled study of women with recurrent urinary tract infections. BMC Microbiol. 2021 Feb 18;21(1):53. doi: 10.1186/s12866-021-02106-4. |
| 27251185 | Derived | Maki KC, Kaspar KL, Khoo C, Derrig LH, Schild AL, Gupta K. Consumption of a cranberry juice beverage lowered the number of clinical urinary tract infection episodes in women with a recent history of urinary tract infection. Am J Clin Nutr. 2016 Jun;103(6):1434-42. doi: 10.3945/ajcn.116.130542. |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D004927 | Escherichia coli Infections |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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