This R21 proposal is in response to RFA AT-03-004 entitled """"""""Cranberry: Urinary Tract Infection and Other Conditions."""""""" Urinary tract infections (UTIs) commonly complicate pregnancy. Colonization of the urinary bladder, known as asymptomatic bacteriuria (ASB), often precedes the development of symptomatic urinary tract infections. A prevention strategy incorporating the daily ingestion of cranberry use for pregnancies with risk factors for the development of ASB could yield health benefits such as the prevention of preterm labor and birth. We propose a Phase I/II double-blind, randomized, placebo-controlled pilot study (R21) to establish protocols for daily cranberry juice ingestion for the prevention of ASB and provide the basis for a larger efficacy trial. We will randomize participants to three treatment arms: Once daily cranberry juice ingestion, three times daily cranberry juice ingestion, or placebo. We will use the prevalence of bacteriuria (defined as greater than 100,000 CFU/mL of a single uropathogen), regardless of symptoms, as the primary outcome measure. We will monitor compliance by several methodologies: Counting of empty containers (or the bottle caps from the containers), evaluating daily dietary diaries maintained by the study subjects, and compiling subject self-reports of percentage estimates of compliance at monthly prenatal care visits. We will treat women with positive urine culture results with oral antibiotic therapy. All women will be followed throughout their pregnancies with attention paid to recurrent lower urinary tract infections, hospitalizations for upper urinary tract infections, preterm labor associated with a urinary tract infection, and delivery outcomes. We believe that the data to be gathered from this investigation will support a large, Phase I/ll multi-center trial and an R01 application.
| Wing, Deborah A; Rumney, Pamela J; Preslicka, Christine W et al. (2008) Daily cranberry juice for the prevention of asymptomatic bacteriuria in pregnancy: a randomized, controlled pilot study. J Urol 180:1367-72 |
