What is this study of a multi-strain probiotic aiming to find out about recurrent vulvovaginal candidiasis?

This study is evaluating how a multi-strain probiotic might affect the risk of recurrence and severity of symptoms in women with recurrent vulvovaginal candidiasis. It aims to understand if the probiotic can reduce the number and severity of infections. The trial is sponsored by The Archer-Daniels-Midland Company and conducted in India.

Who may be eligible for this vulvovaginal candidiasis clinical trial?

Women aged 18 to 50 with a confirmed diagnosis of recurrent vulvovaginal candidiasis may be eligible. Participants must have had at least three episodes in the past year and currently have an active episode confirmed by culture. Pregnant or breastfeeding women and those using antifungal medications recently are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this vulvovaginal candidiasis clinical trial?

Study-related care, including the probiotic or placebo and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan for travel costs as needed.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 50Years

FEMALE

Healthy Volunteers

ID06480604

Pilot Study of a Multi-Strain Probiotic to Reduce Recurrence and Severity of Symptoms in Women Aged 18-50 With Recurrent Vulvovaginal Candidiasis

Led by The Archer-Daniels-Midland Company · Updated on 2024-11-07

126

Participants Needed

Research Sites

N/A

Total Duration

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 probiotics impact. Participants are randomly assigned to one of two groups one group receives a daily dose of 2x109 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

Age: 18Years - 50Years

FEMALE

Healthy Volunteers

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

Research Team

ADM Medical Team

Sanjay Dr Vaze, MBBS, MD

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Pilot Study of a Multi-Strain Probiotic to Reduce Recurrence and Severity of Symptoms in Women Aged 18-50 With Recurrent Vulvovaginal Candidiasis

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria