NCT06480604招募中不适用
A Pilot Clinical Trial Assessing the Effect of a Multi-strain Probiotic on the Risk of Recurrence and Severity of Symptoms in Females With Recurrent Vulvovaginal Candidiasis
The Archer-Daniels-Midland Company6 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2024年10月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 6
- 主要终点
- Incidence of culture-confirmed VVC recurrence between baseline and day 180 as compared to placebo.
研究概览
简要总结
This study evaluates the effect of a multi-strain probiotic on the risk of recurrence and severity of symptoms in females with recurrent vulvovaginal candidiasis (R-VVC).
详细描述
This study aims to investigate the efficacy of live bacteria on the incidence and severity of symptoms of vulvovaginal candidiasis (VVC) recurrence. The trial will be run in India and recruit women with recurrent vulvovaginal candidiasis (R-VVC).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Individuals meeting ALL of the following criteria will be enrolled for the study:
- •Premenopausal women aged 18-50 years.
- •Women with a culture-confirmed active episode caused by Candida spp. (albicans or non-albicans) reported within 24-48 hours of evidence of clinical symptoms. (No medications should have been initiated before the sample for culture is collected).
- •Documented history of recurrence of at least 3 VVC episodes in the last 12 months confirmed by vaginal culture /clinical diagnosis.
- •Culture growth of Candida spp. causing VVC.
- •Random Capillary Blood Glucose of < 110mg/dl.
- •Willingness to consume the study products for the entire study duration.
- •Willing to complete all study procedures and comply with study requirements.
- •Willing to abstain from other supplements or medication.
- •Ready to give voluntary, written, informed consent to participate in the study.
排除标准
- •Individuals meeting ANY of the following criteria will be excluded from the study:
- •Post-menopausal and peri-menopausal women.
- •Pregnant/breast-feeding women.
- •Use of oral or vaginal anti-fungal medication in the last 14 days.
- •Vaginal culture suggestive of bacterial vaginosis (Nugent's score of 7-10), trichomonas vaginalis or Gardnerella vaginalis.
- •Participants found positive for Clotrimazole resistance, by vaginal culture & sensitivity at screening.
- •Known allergy to Clotrimazole.
- •Women not willing to use any form of vaginal medication during the study.
- •Use of vaginal douching.
- •Unwillingness to use an appropriate method of contraception.
- •Diagnosed with compromised immune system, type I and/or type II diabetes mellitus, or malignancies.
- •Use of corticosteroids therapy in the last 30 days.
- •Use of oral/systemic antimicrobial therapy in the last 30 days.
- •Known allergy to the study products or azoles.
- •Individuals with a history of frequent infections requiring antibiotic treatments.
- •Participation in another clinical study(ies) in the last 3 months.
- •Women who, in the opinion of the Investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the study.
- •Women with uncontrolled hypertension with systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg.
- •Heavy alcohol drinkers defined as follows: For men, consuming more than 4 drinks on any day or more than 14 drinks/week. For women, consuming more than 3 drinks on any day or more than 7 drinks/week.
- •History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders that, in the judgment of the Investigator, would interfere with the participant's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the individual at undue risk.
- •Presence of unstable, acutely symptomatic, or life-limiting illness.
- •Use of any supplements (includes probiotics, post-biotics, herbal supplements, synbiotics, enzyme supplements, vitamins with probiotics) in the last 30 days.
结局指标
主要结局
Incidence of culture-confirmed VVC recurrence between baseline and day 180 as compared to placebo.
时间窗: Day 0, Day 180
Efficacy of a multi-strain probiotic on incidence of culture-confirmed VVC recurrence as compared to placebo, where VVC recurrence is defined as a fungal culture positive vaginal swab with at least 2 moderate VVC related symptoms or at least 1 severe VVC related symptom and with VVC free period prior to this incident of at least 7 days.
次要结局
- Time to first recurrence of VVC episode from baseline between probiotic and placebo groups.(Day 0 to first VVC recurrence)
- Change in the number of days with VVC episode between probiotic and placebo groups.(Duration (days) of VVC episodes, Day 0-180.)
- Proportion of Candida albicans positive VVC episodes vs other pathogens between probiotic and placebo groups.(During VVC episodes)
- Quality of life as assessed using SF-36 and compared to baseline and placebo.(Day 0, Day 90, Day 180)
- Change in severity of VVC episodes between probiotic and placebo groups.(During VVC episodes)
- Occurrence of culture-confirmed VVC recurrence between baseline and day 90 as compared to placebo.(Day 0, Day 90)
- Number of administrations of vaginal pessaries during acute VVC episodes as compared to baseline and placebo.(During VVC episodes)
- Changes in vaginal health as assessed by vaginal pH and compared to baseline and placebo.(Day 0, Day 90, Day 180)
- Changes in vaginal microbiology as assessed by vaginal Candida albicans culture and compared to baseline and placebo.(During episodes)
研究者
研究点 (6)
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