Cranberry for Prevention of Bacteriuria in Pregnancy

描述(由申请人提供)：本R21提案是对RFA AT-03-004题为“小红莓：尿路感染和其他条件”的回应。尿路感染(UTIs)通常会导致妊娠并发症。膀胱定植，称为无症状性细菌尿(ASB)，通常先于症状性尿路感染的发展。将怀孕期间每天摄入小红莓与ASB发展的风险因素结合起来的预防策略可以产生健康益处，如预防早产和分娩。 我们提出了一项I/II期双盲、随机、安慰剂对照的试验研究(R21)，以建立预防ASB的每日小红莓汁摄入方案，并为更大规模的疗效试验提供基础。我们将参与者随机分成三个治疗组：每天一次摄入小红莓汁，每天三次摄入小红莓汁，或安慰剂。我们将使用菌尿患病率(定义为单一尿路病原体超过100000 CFU/毫升)作为主要结果衡量标准，而不考虑症状。我们将通过几种方法来监测遵从性：计算空容器(或容器上的瓶盖)的数量，评估研究对象保持的每日饮食日记，以及编制受试者自我报告，估计每月产前护理访问的遵从性百分比。我们将对尿培养阳性的妇女进行口服抗生素治疗。所有妇女将在整个怀孕期间接受跟踪，关注反复发生的下尿路感染、上尿路感染住院治疗、与尿路感染相关的早产以及分娩结果。我们相信，从这项调查中收集的数据将支持一项大型的I/11阶段多中心试验和R01应用。

DESCRIPTION (provided by applicant): 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.