Actively Recruiting
Effect of a Multi-strain Probiotic on the Risk of Recurrence and Symptom Severity in Females With Recurrent Vulvovaginal Candidiasis
Led by The Archer-Daniels-Midland Company · Updated on 2024-11-07
126
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The Archer-Daniels-Midland Company
Lead Sponsor
V
Vedic Lifesciences Pvt. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of a multi-strain probiotic on the risk of recurrence and symptom severity in females with recurrent vulvovaginal candidiasis (R-VVC). This trial aims to study how live bacteria influence the incidence and severity of VVC recurrence in women. The study is conducted in India and targets women with recurring VVC to better understand the probiotic's impact. Participants are randomly assigned to one of two groups: one group receives a daily dose of 2x10^9 Colony Forming Units of a multi-strain probiotic, taken as two capsules once daily for six months. The other group receives a matching placebo for the same duration. This trial uses a triple-blinded design and monitors participants over the six-month treatment period. During the study, participants will be monitored for culture-confirmed VVC recurrence at baseline, day 90, and day 180. Researchers will assess time to first recurrence, episode duration, symptom severity, vaginal health, microbiology, and quality of life using questionnaires. The study also tracks the use of vaginal pessaries during acute episodes and evaluates vaginal pH and Candida cultures. Participant involvement includes compliance with study procedures, abstaining from other supplements or medications, and regular assessments throughout the study period.
CONDITIONS
Brief Title
Effect of a Multi-strain Probiotic on Recurrent Vulvovaginal Candidiasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Premenopausal women aged 18 to 50 years
- Women with a culture-confirmed active episode caused by Candida species within 24-48 hours of clinical symptoms
- Documented history of at least 3 VVC episodes in the past 12 months confirmed by vaginal culture or clinical diagnosis
- Culture growth of Candida species causing VVC
- Random capillary blood glucose less than 110 mg/dl
- Willingness to take study products for the entire duration
- Willing to complete all study procedures and follow study requirements
- Willing to abstain from other supplements or medications
- Ready to give voluntary, written informed consent to participate
You will not qualify if you...
- Post-menopausal and peri-menopausal women
- Pregnant or breastfeeding women
- Use of oral or vaginal antifungal medication in the last 14 days
- Vaginal culture indicating bacterial vaginosis, trichomonas vaginalis, or Gardnerella vaginalis
- Positive for clotrimazole resistance at screening
- Known allergy to clotrimazole
- Unwillingness to use vaginal medication during the study
- Use of vaginal douching
- Unwillingness to use appropriate contraception
- Diagnosed with compromised immune system, diabetes mellitus type I or II, or malignancies
- Use of corticosteroids in the last 30 days
- Use of oral or systemic antimicrobial therapy in the last 30 days
- Known allergy to study products or azoles
- History of frequent infections needing antibiotics
- Participation in another clinical study within the last 3 months
- Considered unlikely to comply with the study
- Uncontrolled hypertension (systolic ≥140 mm Hg or diastolic ≥90 mm Hg)
- Heavy alcohol use (more than 3 drinks per day or 7 per week for women)
- Smokers
- Presence of significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurologic disorders
- Presence of unstable, acutely symptomatic, or life-limiting illness
- Use of supplements including probiotics, post-biotics, herbal supplements, synbiotics, enzyme supplements, or vitamins with probiotics in the last 30 days
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive a daily dose of either a multi-strain probiotic or a placebo for 6 months to assess the effect on vulvovaginal candidiasis recurrence and symptom severity.
Visits at baseline, Day 90, and Day 180 for assessments
Trial Site Locations
Total: 6 locations
1
Anand Multispeciality Hospital
Vadodara, Gujarat, India
Actively Recruiting
2
Life Care Hospital
Nashik, Maharashtra, India
Actively Recruiting
3
AMF's Moraya Multispeciality Hospital
Pune, Maharashtra, India
Actively Recruiting
4
ENT & Vertigo Clinic
Pune, Maharashtra, India
Actively Recruiting
5
Vivaan Hospital
Sopāra, Maharashtra, India
Actively Recruiting
6
Matritva Women's Hospital
Vasai, Maharashtra, India
Actively Recruiting
Research Team
A
ADM Medical Team
S
Sanjay Dr Vaze, MBBS, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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