High-Potency Cranberry Proanthocyanidins and Lactobacilli for Recurrent Urinary Tract Infection Prevention in Women With Type 2 Diabetes: A Prospective Single-Arm Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Study Completion and Retention Rate
研究概览
简要总结
The purpose of this prospective, single-arm feasibility study was to evaluate the operational feasibility, tolerability, safety, and exploratory clinical outcomes of an oral supplement combining standardized cranberry proanthocyanidins (PACs) and a multi-strain Lactobacillus formulation in women with type 2 diabetes mellitus and a documented history of recurrent urinary tract infections (rUTIs).
Participants received a 60-day active intervention consisting of a combined capsule taken twice daily, followed by a 120-day observation period without study intervention, for a total follow-up duration of 180 days. Primary feasibility outcomes included screening and enrollment metrics, retention rate at day 180, and tolerability/adverse event rates. Exploratory endpoints included the incidence of microbiologically confirmed symptomatic UTIs and changes in antibiotic prescription rates compared with pre-enrollment history.
详细描述
Women with type 2 diabetes mellitus (T2DM) are disproportionately affected by recurrent urinary tract infections due to glucosuria, impaired innate immune defenses, and urogenital dysbiosis, which is often compounded by the use of sodium-glucose cotransporter-2 (SGLT2) inhibitors.
This prospective, open-label, single-arm feasibility study was conducted at the National Institute of Endocrinology in Tbilisi, Georgia. Eligible participants were women aged 40 to 75 years with established T2DM (HbA1c 6.5%-10.0%) and a confirmed history of recurrent UTIs (defined as >=2 episodes in the prior 12 months or >=1 in the prior 6 months) without active infection at enrollment.
The study protocol comprised:
- Screening window: up to 14 days to confirm eligibility and baseline stability.
- Active intervention phase: 60 consecutive days of oral supplementation with a commercial capsule containing 72 mg of standardized cranberry PACs and 2x10^9 CFU of a multi-strain Lactobacillus formulation (L. rhamnosus, L. acidophilus, L. casei) taken twice daily with meals (total 144 mg PACs daily).
- Observation phase: 120 days of prospective follow-up without study supplementation.
Standard glucose-lowering therapies (including metformin and SGLT2 inhibitors) were maintained unchanged throughout the 180-day study. The study was designed to generate operational, safety, and preliminary signal data to inform the sample size calculation and methodological design of a future randomized, double-blind, placebo-controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 40 to 75 years.
- •Established diagnosis of type 2 diabetes mellitus for >= 12 months.
- •Baseline glycated hemoglobin (HbA1c) between 6.5% and 10.0%.
- •Documented history of recurrent urinary tract infections (>= 2 episodes in the preceding 12 months or >= 1 episode in the preceding 6 months).
- •Absence of active symptomatic UTI at enrollment, verified by screening urine analysis and culture.
- •Maintained on stable glucose-lowering therapy for at least 3 months prior to enrollment.
- •Willing and able to comply with the 60-day supplementation and 180-day follow-up protocol.
- •Provided written informed consent.
排除标准
- •Active, symptomatic urinary tract infection at the time of screening.
- •Known anatomical or functional urinary tract abnormalities (e.g., neurogenic bladder, urinary tract obstruction, indwelling catheter).
- •Severe renal impairment (eGFR < 30 mL/min/1.73 m2) or end-stage renal disease.
- •Severe hepatic impairment or active malignancy.
- •Routine use of systemic antibiotic prophylaxis for UTI within 30 days prior to screening.
- •Regular intake of cranberry-containing supplements, D-mannose, or commercial probiotic formulations within 30 days prior to enrollment.
- •Known allergy or hypersensitivity to cranberry extracts, proanthocyanidins, or any excipient in the study formulation.
- •Pregnancy, lactation, or women planning pregnancy during the study duration.
研究组 & 干预措施
Active Supplementation Arm
Participants received oral capsules containing standardized cranberry proanthocyanidins (72 mg) and multi-strain Lactobacillus (2x10^9 CFU) twice daily for 60 consecutive days, followed by a 120-day observation phase.
干预措施: Cranberry Proanthocyanidins and Lactobacilli (Dietary Supplement)
结局指标
主要结局
Study Completion and Retention Rate
时间窗: Day 180
Proportion of enrolled participants who successfully completed the entire 180-day protocol (comprising the 60-day active supplementation phase and the 120-day observation phase) without premature discontinuation.
次要结局
- Incidence of Symptomatic Recurrent Urinary Tract Infections (rUTIs)(Day 1 to Day 180)
- Frequency of Antibiotic Courses Prescribed for UTI(Day 1 to Day 180)
- Incidence of Treatment-Emergent Adverse Events(Day 1 to Day 60 (active intervention period))