研究评估M247乳酸乳杆菌在预防和治疗复发尿路感染方面的疗效

实验性的：CRISPACT® 集团

该组参与者将每日口服1包iNatal Duo®（含动物双歧杆菌乳亚种BB-12和屎肠球菌L3），持续30天，同时口服CRISPACT®（卷曲乳杆菌M247）90天。 该干预旨在评估与对照治疗相比，益生菌疗法在12个月的随访期内是否能降低复发性尿路感染（rUTI）的发生频率。

膳食补充剂：凝结芽孢杆菌M247

CRISPACT® (卷曲乳杆菌 M247)，PharmExtracta S.p.A

膳食补充剂：iNatal-Duo®（含动物双歧杆菌乳亚种BB-12和屎肠球菌L3）

iNatal-Duo®, PharmExtracta S.p.A

有源比较器：对照组

该组参与者将每天口服一袋iNatal-Duo®，持续30天，不额外补充益生菌。 该组将作为对照组，以评估补充益生菌在预防复发性尿路感染复发方面的比较效果。

膳食补充剂：iNatal-Duo®（含动物双歧杆菌乳亚种BB-12和屎肠球菌L3）

iNatal-Duo®, PharmExtracta S.p.A

Cumulative number of symptomatic UTI recurrences per participant

Cumulative number of investigator-confirmed, urine-culture-supported symptomatic UTI recurrences experienced by each participant from randomization through the 12-month follow-up

尿路症状变化（国王健康问卷）

采用国王健康问卷（KHQ）进行评估，该问卷是针对泌尿系统症状的经过验证的特定疾病问卷。
评分范围为0至100分，分数越高表明症状越严重，对生活质量的影响也越大。

Change in health-related quality of life (EQ-5D)

Assessment using the EuroQol 5-Dimension questionnaire (EQ-5D). The individual health dimensions and perceived health status were assessed separately.

Change in sexual function

Assessment using the Female Sexual Function Index-6 (FSFI-6). The available sexual-health measures were assessed separately.

Treatment adherence

Proportion of participants taking at least 90% of the scheduled doses of the assigned probiotic supplementation, assessed using participants' treatment diaries and counts of returned unused sachets.

Treatment tolerability

Participants' overall assessment of treatment tolerability, categorized as excellent, good, fair, or poor, together with the number of treatment discontinuations.

Safety and adverse events

Number and proportion of participants experiencing adverse events, serious adverse events, vaginitis, bacterial vaginosis, or other genital infections during the study.

Participants experiencing at least one symptomatic UTI recurrence through month 3

Number and proportion of participants experiencing at least one investigator-confirmed, urine-culture-supported symptomatic UTI recurrence from randomization through the 3-month assessment.

Participants experiencing at least one symptomatic UTI recurrence through month 12

Number and proportion of participants experiencing at least one investigator-confirmed, urine-culture-supported symptomatic UTI recurrence from randomization through the 12-month assessment.

Pelvic pain and urgency/frequency symptom burden at month 3

Assessment using the Pelvic Pain and Urgency/Frequency (PUF) questionnaire. Total scores range from 0 to 35, with higher scores indicating greater symptom severity.

Cumulative number of symptomatic UTI recurrences per participant through month 3

Cumulative number of investigator-confirmed, urine-culture-supported symptomatic UTI recurrences experienced by each participant from randomization through the 3-month assessment.

Participants requiring culture-guided antibiotic therapy for a symptomatic UTI recurrence

Number and proportion of participants experiencing at least one investigator-confirmed, urine-culture-supported symptomatic UTI recurrence whose symptoms did not improve to a clinically meaningful extent within 3 days of an initial non-antibiotic regimen. This regimen comprised oral D-mannose 500 mg three times daily, taken after voiding and away from meals, together with ibuprofen 400 mg once daily in the morning after breakfast, with a second 400-mg dose 12 hours later when required. Participants reporting an allergy to ibuprofen received paracetamol 1,000 mg once daily, with a second 1,000-mg dose 12 hours later when required. Participants without clinically meaningful improvement by day 3 received antibiotic therapy selected according to urine-culture and antimicrobial-susceptibility results. The denominator was the number of participants experiencing at least one confirmed recurrence; each participant was counted only once if antibiotic therapy was required for any recurrence.