CTRI/2024/07/071175尚未招募4 期
A randomized, triple blinded, placebo controlled, parallel-group study toassess the effect of a multi-strain probiotic on the risk of recurrenceand severity of symptoms in females with recurrent vulvovaginal candidiasis(R-VVC) - NI
Dr Malwina Naghibi0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Premenopausal women aged 18-50 years
- •2.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)
- •3.Documented history of recurrence of at least 3 VVC episodes in the last 12 months confirmed by vaginal culture per clinical diagnosis
- •4.Culture growth of Candida spp. causing VVC
- •5.Random Capillary Blood Glucose of less than 110mg per dl.
- •6.Willingness to consume the study products for the entire study duration.
- •7.Willing to complete all study procedures and comply with study requirements.
- •8.Willing to abstain from other supplements or medication.
- •9.Ready to give voluntary, written, informed consent to participate in the study.
排除标准
- •1.Post-menopausal and peri-menopausal women.
- •2.Pregnant/breast-feeding women.
- •3.Use of oral or vaginal anti-fungal medication in the last 14 days.
- •4.Vaginal culture suggestive of bacterial vaginosis (Nugent’s score of 7-10), trichomonas vaginalis or Gardnerella vaginalis.
- •5.Participants found positive for Clotrimazole resistance by vaginal culture & sensitivity at screening.
- •6.Known history of allergy to Clotrimazole.
- •7.Women not willing to use any form of vaginal medication during the study.
- •8.Use of vaginal douching.
- •9.Unwillingness to use an appropriate method of contraception.
- •10.Diagnosed with compromised immune system, diabetes, or malignancies.
- •11.Use of Corticosteroids therapy in the last 30 days.
- •12.Use of oral or systemic antimicrobial therapy in the last 30 days.
- •13.Known allergy to the study products or azoles.
- •14.Individuals with a history of frequent infections requiring antibiotic treatments.
- •15.Participation in another clinical study(ies) in the last 3 months.
- •16.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.
- •17.Women with uncontrolled hypertension with systolic blood pressure more than equal to 140 mm Hg and or diastolic blood pressure more than equal to 90 mm Hg.
- •18.Heavy alcohol drinkers defined as follows: For men, consuming more than 4 drinks on any day or more than 14 drinks per week. For women, consuming more than 3 drinks on any day or more than 7 drinks per week.
- •19.Smokers
- •20.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 ability provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the individual at undue risk.
- •21.Presence of unstable, acutely symptomatic, or life-limiting illness.
- •22.Use of any supplements (includes probiotics, post-biotics, herbal supplements, synbiotics, enzyme supplements, vitamins with probiotics) in the last 30 days
研究者
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