Actively Recruiting
Effect of a Multi-strain Probiotic on Recurrent Vulvovaginal Candidiasis
Led by The Archer-Daniels-Midland Company · Updated on 2024-11-07
126
Participants Needed
6
Research Sites
37 weeks
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
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).
CONDITIONS
Official Title
Effect of a Multi-strain Probiotic on Recurrent Vulvovaginal Candidiasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Premenopausal women aged 18-50 years
- Culture-confirmed active vulvovaginal candidiasis episode within 24-48 hours of symptom onset
- History of at least 3 VVC episodes in the last 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 consume study products for entire study duration
- Willing to complete all study procedures and comply with study requirements
- Willing to abstain from other supplements or medications
- Able to give voluntary, written informed consent
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 by vaginal culture and sensitivity
- Known allergy to clotrimazole
- Unwillingness to use any vaginal medication during the study
- Use of vaginal douching
- Unwillingness to use appropriate contraception
- Diagnosed with compromised immune system, type I or II diabetes mellitus, or malignancies
- Use of corticosteroid therapy 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 antibiotic treatments
- Participation in another clinical study in the last 3 months
- Considered by investigator to be poor clinical attendees or unlikely to comply
- Uncontrolled hypertension (systolic ≥140 mm Hg or diastolic ≥90 mm Hg)
- Heavy alcohol consumption (more than 3 drinks/day or 7 drinks/week for women)
- Smokers
- History or presence of significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurologic disorders interfering with consent or study compliance
- 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
AI-Powered Screening
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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
CONTACT
S
Sanjay Dr Vaze, MBBS, MD
CONTACT
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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