Probiotic: Participants in this arm will receive a daily dose of 2x10\^9 Colony Forming Units (CFU) of a multi strain probiotic (live bacterium), corresponding to 2 capsules once daily, for 6 months.
Placebo: Participants in this arm will receive an equivalent placebo for the duration of the study (6 months).
Study summary
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).
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Incidence of culture-confirmed VVC recurrence between baseline and day 180 as compared to placebo. — Day 0, Day 180 Efficacy of a multi-strain probiotic on incidence of culture-confirmed VVC recurrence as compared to placebo, where VVC recurrence is defined as a fungal culture positive vaginal swab with at least 2 moderate VVC related symptoms or at least 1 severe VVC related symptom and with VVC free period prior to this incident of at least 7 days.
Trial sites (6)
Facility
City
Region
Status
Anand Multispeciality Hospital
Vadodara
Gujarat
Recruiting
Life Care Hospital
Nashik
Maharashtra
Recruiting
AMF's Moraya Multispeciality Hospital
Pune
Maharashtra
Recruiting
ENT & Vertigo Clinic
Pune
Maharashtra
Recruiting
Vivaan Hospital
Sopāra
Maharashtra
Recruiting
Matritva Women's Hospital
Vasai
Maharashtra
Recruiting
More The Archer-Daniels-Midland Company trials in India
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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