Using a multi-strain probiotic to reduce recurrent vulvovaginal candidiasis

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

This study is testing if a special probiotic can help women aged 18-50 with frequent yeast infections feel better and have fewer episodes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: The Archer-Daniels-Midland Company (Industry-sponsored)
• Locations: 6 sites (Vadodara, Gujarat and 5 other locations)
• Trial ID: NCT06480604 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a multi-strain probiotic in reducing the recurrence and severity of symptoms in women suffering from recurrent vulvovaginal candidiasis (R-VVC). The trial will involve premenopausal women aged 18-50 who have a documented history of multiple VVC episodes. Participants will be randomly assigned to receive either the probiotic or a placebo, and their outcomes will be monitored over the study duration. The research is being conducted in India at multiple hospital locations.

Who should consider this trial

Good fit: Ideal candidates for this study are premenopausal women aged 18-50 with a history of at least three culture-confirmed episodes of vulvovaginal candidiasis in the past year.

Not a fit: Patients who do not have recurrent vulvovaginal candidiasis or those with other underlying health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new preventive treatment option for women suffering from recurrent vulvovaginal candidiasis.

How similar studies have performed: Other studies have shown promising results with probiotics in managing similar conditions, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

Individuals meeting ALL of the following criteria will be enrolled for the study:

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 /clinical diagnosis.
4. Culture growth of Candida spp. causing VVC.
5. Random Capillary Blood Glucose of \< 110mg/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.

Exclusion Criteria:

Individuals meeting ANY of the following criteria will be excluded from the study:

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 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, type I and/or type II diabetes mellitus, or malignancies.
11. Use of corticosteroids therapy in the last 30 days.
12. Use of oral/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 ≥ 140 mm Hg and/or diastolic blood pressure ≥ 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/week. For women, consuming more than 3 drinks on any day or more than 7 drinks/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'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.
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.

Where this trial is running

Vadodara, Gujarat and 5 other locations

• Anand Multispeciality Hospital — Vadodara, Gujarat, India (Recruiting)
• Life Care Hospital — Nashik, Maharashtra, India (Recruiting)
• AMF's Moraya Multispeciality Hospital — Pune, Maharashtra, India (Recruiting)
• ENT & Vertigo Clinic — Pune, Maharashtra, India (Recruiting)
• Vivaan Hospital — Sopāra, Maharashtra, India (Recruiting)
• Matritva Women's Hospital — Vasai, Maharashtra, India (Recruiting)

Study contacts

• Study coordinator: ADM Medical Team

Conditions Vulvovaginal Candidiasis; Microbiome; Probiotic; Recurrent; Vulvovaginal; Candidiasis; RVVC; Vaginal