Recurrent vulvovaginal candidiases
Conditions
Interventions
Group I - SymBiElle (Experimental): Participants will receive 1 capsule of SymBiElle by oral route, every 12 hours with meals (2 capsules per day in total) for 90 days. The capsule is a cooperative mi
Sponsors
Hermanos Ameijeiras Surgical Clinical Hospital
Eligibility
Sex/Gender
Female
Age
19 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Female patients residing in Cuba, aged 19–55 years, with an active sexual life. 2. Female patients residing in Cuba, aged 19–55 years, with recurrent vulvovaginal Candida infection confirmed by vaginal exudate and/or clinical diagnosis, who provide informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received antifungal or antibiotic treatment. 2. Pregnant or breastfeeding patients. 3. Women with non-gynecological infections who have initiated short-term oral antibiotic treatment within 72 hours prior to enrollment. 4. Immunocompromised patients or those under steroid treatment at the time of evaluation or within the last 15 days. 5. Patients with other sexually transmitted infections (STIs). 6. Patients with chronic diseases such as diabetes, cardiovascular disease, chronic infections, food or antibiotic allergies, or those who have used any anti-inflammatory drugs during the last month. 7. Patients currently receiving another investigational product. 8. Patients with mental disorders that may limit adherence to clinical trial requirements and hinder data collection, treatment, or follow-up. 9. Women under anticoagulant therapy, such as warfarin (Coumadin), aspirin, or clopidogrel (Plavix). 10. Women with vitamin K deficiency. 11. Women with retinal damage known as retinitis pigmentosa.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Vaginal Microbiome (16S rRNA sequencing to determine the abundance of Lactobacillus crispatus, Gardnerella, Candida spp. The microbiome will be assessed through sequencing of the 16S ribosomal subunit (16S rRNA V3-V4)). Measurement time: At baseline and, 90 days 2. Taxonomic Profile Analysis (It will be conducted using PICRUSt to determine inflammation index, alpha diversity, and beta diversity). Measurement time: At baseline and, 90 days 3. Compositional Analysis: Prediction of functional markers (orthologous genes) from microbiome data using LEfSe (Linear Discriminant Analysis Effect Size), at both taxonomic and functional levels). Measurement time: At baseline and, 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in Vaginal pH (pH value using a vaginal secretion sample). Measurement time: At baseline and, 45 days, 90 days and 120 days 2. Nugent Score ( A Nugent score of 0 to 3 represents a healthy microbiota, 4 to 6 an intermediate microbiota, and 7 to 10 confirms bacterial vaginosis). Measurement time: At baseline and, 45 days, 90 days and 120 days 3. Quality of life (SF-36 Health Survey. The SF-36 health survey in Spanish will be administered, assessing various aspects of health-related quality of life. The SF-36 covers physical and mental health components, including: physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health). Measurement time: At baseline and, 45 days, 90 days and 120 days 4. Adverse Effects - AE (Presence of AE (No apparent AE, Possible AE, Similar to AE, AE); Intensity of AE (Mild: does not restrict daily activities, Moderate: partially restricts daily activities, Severe: inability to perform daily activities)). Measurement time: At baseline and, 45 days, 90 days and 120 days | — |
Countries
Cuba
Contacts
Public ContactGissel Garcia Menendez
Hermanos Ameijeiras Clinical Surgical Hospital
Outcome results
None listed