Effect of a Multi-strain Probiotic on Recurrent Vulvovaginal Candidiasis

Launched by THE ARCHER-DANIELS-MIDLAND COMPANY · Jun 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a special type of probiotic (which are good bacteria) can help women who frequently experience a condition called recurrent vulvovaginal candidiasis (R-VVC), commonly known as yeast infections. The goal is to see if taking this multi-strain probiotic can reduce the chances of getting these infections again and lessen the symptoms when they do occur.

To participate in this study, women must be aged 18 to 50 and have had at least three yeast infection episodes confirmed by a doctor in the past year. They need to be willing to take the study product and follow the study guidelines without using other medications or supplements during the trial. Participants will be asked to provide consent and complete various study procedures. The trial is currently recruiting, so if you or someone you know fits the criteria, it might be a chance to help in understanding better ways to manage this common condition.

Gender

FEMALE

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.