Cranberry for Prevention of Bacteriuria in Pregnancy

蔓越莓预防妊娠期菌尿

• 批准号: 6881556
• 负责人: Deborah A Wing
• 金额: $ 19.16万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-04-15 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6881556
• 关键词: alternative medicine; bacteriuria; clinical research; clinical trial phase I; clinical trial phase II; diet therapy; disease /disorder prevention /control; fruit; human pregnant subject; human therapy evaluation; longitudinal human study; nutrition related tag; outcomes research; patient oriented research; pregnancy infection; urinalysis; women' s health

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.

描述（由申请人提供）：本R21提案是对RFA AT-03-004题为“蔓越莓：尿路感染和其他情况”的回应。尿路感染（uti）通常使妊娠复杂化。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。一项预防战略包括在有ASB发展风险因素的怀孕期间每天摄入蔓越莓，可以产生健康益处，如预防早产和分娩。