Stonehouse Welma, Benassi-Evans Bianca, Bednarz Jana, Vincent Andrew D
Health and Biosecurity, Human Health Program, Commonwealth Scientific Industrial Research Organization (CSIRO), Adelaide, South Australia, Australia.
Health and Biosecurity, Human Health Program, Commonwealth Scientific Industrial Research Organization (CSIRO), Adelaide, South Australia, Australia.
Am J Clin Nutr. 2025 Apr;121(4):932-941. doi: 10.1016/j.ajcnut.2025.01.022. Epub 2025 Jan 23.
BACKGROUND: High prevalence of urinary tract infections (UTI), including cystitis, and concern for antimicrobial resistance justify safe and effective nonantibiotic therapies for prevention of recurrent UTI (rUTI). OBJECTIVES: This study investigated the effect of a whole cranberry fruit powder supplement on incidence of culture-confirmed UTI (primary outcome) in females with rUTI history. METHODS: This multicenter, 6-mo, randomized, placebo-controlled, double-blind study enrolled 150 healthy females [18-65 y, body mass index (BMI) >17.5 and <35 kg/m] with rUTI defined as ≥3 UTIs in the last year or ≤2 UTIs in the last 6 mo, excluding those with >5 UTIs in the last 6 mo. Participants consumed either 1 capsule of 500 mg/d of whole cranberry powder (Pacran) or placebo. Culture-confirmed UTIs (>10cfu/L) were assessed throughout the intervention period at unscheduled clinic visits whenever participants experienced UTI symptoms and at baseline, 3- and 6-mo clinic visits. Symptomatic suspected UTIs were defined as participant-reported UTI-associated symptoms at unscheduled visits. RESULTS: Whole cranberry powder capsules reduced culture-confirmed UTI risk compared with placebo by 52% (adjusted relative risk [RR]: 0.48; 95% confidence interval [CI]: 0.26, 0.87; P = 0.01); reduced Escherichia coli UTIs (RR: 0.49; 95% CI: 0.24, 1.01; P = 0.05); reduced incidence of UTI with urinary frequency and urgency symptomatology (RR: 0.29; 95% CI:0.13, 0.63; P < 0.01); delayed time to first UTI episode (adjusted hazard ratio [HR]: 0.36; 95% CI: 0.18, 0.74; P = 0.01); and reduced the mean total number of UTIs per participant (adjusted incidence rate ratio IRR: 0.41; 95% CI: 0.21, 0.79; P = 0.01). Significant differences between groups in incidence of symptomatic suspected UTIs and culture-confirmed dysuria were not observed. Exploratory scores for UTI-related female sexual matters, assessed in a subset of sexually active, consenting females, did not differ significantly between groups. No safety concerns were reported. CONCLUSION: This study shows that whole cranberry powder capsules do not impact safety markers and reduce the incidence of culture-confirmed UTI and several other UTI-related outcomes in healthy females with rUTI history. This trial was registered at clinicaltrials.gov asNCT03042273.
背景：包括膀胱炎在内的尿路感染（UTI）患病率较高，且对抗菌素耐药性的担忧使得预防复发性尿路感染（rUTI）的安全有效非抗生素疗法具有合理性。 目的：本研究调查了全蔓越莓果粉补充剂对有rUTI病史女性中经培养确诊的UTI发病率（主要结局）的影响。 方法：这项多中心、为期6个月的随机、安慰剂对照、双盲研究纳入了150名健康女性[年龄18 - 65岁，体重指数（BMI）>17.5且<35 kg/m²]，rUTI定义为过去一年中≥3次UTI或过去6个月中≤2次UTI，排除过去6个月中>5次UTI的女性。参与者每天服用1粒500毫克的全蔓越莓粉胶囊（Pacran）或安慰剂。在整个干预期内，每当参与者出现UTI症状时，在非计划门诊就诊时以及在基线、3个月和6个月门诊就诊时评估经培养确诊的UTI（>10⁵cfu/L）。有症状的疑似UTI定义为参与者在非计划就诊时报告的与UTI相关的症状。 结果：与安慰剂相比，全蔓越莓粉胶囊将经培养确诊的UTI风险降低了52%（调整相对风险[RR]：0.48；95%置信区间[CI]：0.26，0.87；P = 0.01）；降低了大肠杆菌UTI（RR：0.49；95% CI：0.24，1.01；P = 0.05）；降低了伴有尿频和尿急症状的UTI发病率（RR：0.29；95% CI：0.13，0.63；P < 0.01）；延迟了首次UTI发作时间（调整风险比[HR]：0.36；95% CI：0.18，0.74；P = 0.01）；并降低了每位参与者UTI的平均总数（调整发病率比IRR：0.41；95% CI：0.21，0.79；P = 0.01）。未观察到两组在有症状的疑似UTI发病率和经培养确诊的排尿困难方面的显著差异。在一部分有性行为且表示同意的女性中评估的UTI相关女性性问题的探索性评分在两组之间无显著差异。未报告安全问题。 结论：本研究表明，全蔓越莓粉胶囊不影响安全指标，并降低了有rUTI病史的健康女性中经培养确诊的UTI发病率以及其他一些与UTI相关的结局。该试验在clinicaltrials.gov上注册为NCT03042273。
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