Oral Lactobacillus Crispatus M247 as an Add-on to Enterococcus Faecium L3 and Bifidobacterium Animalis Subsp. Lactis BB-12 for the Prevention of Recurrent Urinary Tract Infections in Women: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 3
- 主要终点
- Cumulative number of symptomatic UTI recurrences per participant
研究概览
简要总结
This randomized, open-label, controlled clinical trial evaluates the efficacy and safety of Lactobacillus crispatus M247 (CRISPACT®) in preventing recurrent urinary tract infections (rUTIs) in women. The study enrolls 84 adult female participants with a history of recurrent UTIs, defined as ≥3 episodes in the past year or ≥2 episodes in the past six months. Participants are randomized into two groups: the Probiotic Group, receiving iNatal Duo® (containing Bifidobacterium animalis subsp. lactis BB-12 and Enterococcus faecium L3) for 30 days plus CRISPACT® (Lactobacillus crispatus M247) administered orally for 90 days; and the Control Group, receiving iNatal Duo® alone for 30 days without additional probiotic supplementation. The primary outcome is the reduction in the frequency of rUTIs over 12 months, while secondary outcomes include symptom improvement, quality of life, and safety assessments.
详细描述
Recurrent urinary tract infections (rUTIs) represent a significant public health issue, disproportionately affecting women with hormonal fluctuations, sexual activity-related risks, or prior antibiotic exposure. Standard treatment relies on antibiotic therapy, which, while effective, contributes to antimicrobial resistance, microbiota imbalance, and increased recurrence risk. Probiotics, particularly Lactobacillus crispatus, have demonstrated potential in restoring urogenital microbiota balance and reducing uropathogen overgrowth.
This study aims to assess whether CRISPACT® (Lactobacillus crispatus M247), administered orally, provides superior protection against rUTIs compared with standard care using iNatal Duo® alone. The study follows a randomized, controlled design with 84 participants allocated to two parallel arms. The Probiotic Group receives iNatal Duo® for 30 days combined with CRISPACT® for 90 days, while the Control Group receives iNatal Duo® alone for 30 days without additional probiotic supplementation.
The primary objective is to evaluate the reduction in rUTI recurrence over a 12-month follow-up period, assessed through clinical diagnosis and patient-reported data. Secondary objectives include evaluation of symptom relief, patient-reported quality-of-life outcomes (EQ-5D, King's Health Questionnaire), and safety and tolerability of the probiotic intervention. The study seeks to provide clinical evidence supporting probiotic-based strategies for rUTI prevention and reduction of antibiotic dependence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women aged 18-65 years.
- •History of recurrent urinary tract infections (rUTIs), defined as ≥3 episodes in the past year or ≥2 episodes in the past 6 months.
- •Able to provide informed consent and comply with study procedures.
排除标准
- •Age <18 years.
- •Ongoing complicated cystitis or uncomplicated pyelonephritis.
- •History of urological abnormalities or kidney stones.
- •Recent sexually transmitted infection or bacterial vaginosis, or history of recurrent bacterial vaginosis.
- •Risk factors for sexually transmitted diseases.
- •Ongoing pregnancy, planning pregnancy, or breastfeeding.
- •Diagnosis of diabetes mellitus.
- •Diagnosis of HIV infection or other immunocompromised states.
- •Recent history of drug or alcohol abuse.
- •Persistent symptoms and/or pyuria after acute UTI treatment.
- •Uterine, cervical, vaginal, or urethral cancer.
- •Urethral diverticulum.
- •Tuberculous, radiation-induced, cyclophosphamide-induced, or chemical cystitis.
- •Benign or malignant bladder tumors.
- •Recent diagnosis of vaginitis.
- •Known hypersensitivity to study products.
- •Failure to provide informed consent.
研究组 & 干预措施
CRISPACT® Group
Participants in this group will receive iNatal Duo® (containing Bifidobacterium animalis subsp. lactis BB-12 and Enterococcus faecium L3) 1 sachet per day orally for 30 days, along with CRISPACT® (Lactobacillus crispatus M247) administered orally for 90 days. The intervention aims to assess whether probiotic therapy reduces the frequency of recurrent urinary tract infections (rUTIs) over a 12-month follow-up period compared with control treatment.
干预措施: Lactobacillus crispatus M247 (Dietary Supplement)
CRISPACT® Group
Participants in this group will receive iNatal Duo® (containing Bifidobacterium animalis subsp. lactis BB-12 and Enterococcus faecium L3) 1 sachet per day orally for 30 days, along with CRISPACT® (Lactobacillus crispatus M247) administered orally for 90 days. The intervention aims to assess whether probiotic therapy reduces the frequency of recurrent urinary tract infections (rUTIs) over a 12-month follow-up period compared with control treatment.
干预措施: iNatal-Duo® (containing Bifidobacterium animalis subsp. lactis BB-12 and Enterococcus faecium L3) (Dietary Supplement)
Control Group
Participants in this group will receive iNatal-Duo® alone 1 sachet per day orally for 30 days without additional probiotic supplementation. This group will serve as a control to evaluate the comparative effectiveness of probiotic supplementation in preventing rUTI recurrence.
干预措施: iNatal-Duo® (containing Bifidobacterium animalis subsp. lactis BB-12 and Enterococcus faecium L3) (Dietary Supplement)
结局指标
主要结局
Cumulative number of symptomatic UTI recurrences per participant
时间窗: 12 months
Cumulative number of investigator-confirmed, urine-culture-supported symptomatic UTI recurrences experienced by each participant from randomization through the 12-month follow-up
Number of recurrent urinary tract infection (rUTI) episodes
时间窗: 12 months
The primary outcome assesses the number of clinically diagnosed recurrent urinary tract infection episodes during the 12-month follow-up period in participants receiving CRISPACT® (Lactobacillus crispatus M247) plus iNatal Duo® compared with those receiving iNatal Duo® alone.
次要结局
- Change in pelvic pain and urgency/frequency symptoms(3 months)
- Treatment adherence(3 months)
- Treatment tolerability(3 months)
- Safety and adverse events(12 months)
- Participants experiencing at least one symptomatic UTI recurrence through month 3(3 months)
- Participants experiencing at least one symptomatic UTI recurrence through month 12(12 months)
- Cumulative number of symptomatic UTI recurrences per participant through month 3(3 months)
- Participants requiring culture-guided antibiotic therapy for a symptomatic UTI recurrence(12 months)
- Pelvic pain and urgency/frequency symptom burden at month 3(3 months)
- Role of anamnestic factors on development of rUTIs(Baseline, 3 months, 12 months)
- Change in urinary symptoms (King's Health Questionnaire)(Baseline, 3 months)
- Change in pelvic pain and urgency/frequency symptoms(Baseline, 3 months)
- Change in health-related quality of life (EQ-5D)(Baseline, 3 months)
- Change in sexual function(Baseline, 3 months)
研究者
Dr. Amjad Khan
Professor of Clinical Biochemistry and Experimental medicine
Liaquat University of Medical & Health Sciences