Cranberry for Prevention of Bacteriuria in Pregnancy

描述（由申请人提供）：本R21提案是对标题为“蔓越莓：尿路感染和其他疾病”的RFA AT-03-004的回应。尿路感染（UTIs）通常使妊娠并发症。膀胱定植，称为无症状菌尿（ASB），通常先于症状性尿路感染的发展。一种预防策略，包括每天摄入蔓越莓用于怀孕与ASB发展的风险因素，可以产生健康的好处，如预防早产和分娩。 我们提出了一项I/II期双盲，随机，安慰剂对照的初步研究（R21），以建立每日摄入蔓越莓汁预防ASB的方案，并为更大的疗效试验提供基础。我们将参与者随机分为三个治疗组：每天一次蔓越莓汁摄入，每天三次蔓越莓汁摄入，或安慰剂。我们将使用菌尿的患病率（定义为大于100，000 CFU/mL的单一尿路病原体），无论症状如何，作为主要结局指标。我们将通过以下几种方法监测依从性：计数空容器（或容器中的瓶盖），评估研究受试者的每日饮食日记，以及在每月产前护理访视时编制受试者自我报告的依从性百分比估计值。我们将用口服抗生素治疗尿培养结果阳性的妇女。所有女性将在整个妊娠期间接受随访，关注复发性下尿路感染、上尿路感染住院、与尿路感染相关的早产和分娩结局。我们认为，从本研究中收集的数据将支持大型I/II期多中心试验和R 01申请。

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.