Evaluation of the effect of the SymBiElle for vaginal health

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Effect of the Symbiotic Formulation SymBiElle™ on the Reduction of Recurrence of Vulvovaginal Candidiasis through Modulation of the Vaginal Microbiome

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Chauvell LLC : 793E.Foothill Blvd,Ste 37 San Luis Obispo ,CA93405. USA

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Gissel

Last name:

Garcia Menendez

Medical Specialty :

Bachelor in Biochemistry, Ph.D. in Health Sciences

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal address:

San Lazaro # 701 esq. to Belascoain, Centro Habana

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78761952

Email address:

gisselgarcia2805@gmail.com [1]

gisselgarcia@infomed.sld.cu [2]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, Hermanos Ameijeiras Surgical Clinical Hospital, Ahmed Menocal Alayon MD, Second-degree specialist in obstetrics and gynecology

Havana, Ramon Gonzalez Coro Gyneco-Obstetric teaching hospital, Niobys Maya Sanchez Ramirez MD, Second-degree specialist in obstetrics and gynecology

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

16/03/2026

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Recurrent vulvovaginal candidiases

Intervention(s):

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 microbial consortium, formulated based on ecological microbiology and systems biology, leveraging the synergy among its components to maximize its impact on vaginal health. The product will be presented in enteric-coated capsules to protect microbial viability and ensure targeted release in the small intestine, consistent with its use as an oral supplement. Group II – Placebo (Control): Participants will receive 1 capsule of microcrystalline cellulose by oral route, every 12 hours with meals (2 capsules per day in total) for 90 days.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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

Key secondary outcomes:

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

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Female

Minimum age:

19 years

Maximum age:

55 years

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:

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

Target sample size:

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Gissel

Last Name:

Garcia Menendez

Specialty:

Bachelor in Biochemistry, Ph.D. in Health Sciences

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal Address:

San Lazaro # 701 esq. to Belascoain. Centro Habana

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78761952

Email :

gisselgarcia2805@gmail.com [1]

gisselgarcia@infomed.sld.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Gissel

Last Name:

Garcia Menendez

Specialty:

Bachelor in Biochemistry, Ph.D. in Health Sciences

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal Address:

San Lazaro # 701 esq. to Belascoain. Centro Habana

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78761952

Email :

gisselgarcia2805@gmail.com [1]

gissselgarcia@infomed.sld.cu [3]

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Hermanos Ameijeiras Surgical Clinical Hospital

Ramon Gonzalez Coro Gyneco-Obstetric teaching hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

10/01/2026

Postal address of Ethic Committee :

San Lazaro # 701 esq. a Belascoain, Centro Habana, ZC:10400, Havana, Cuba

Calle 17 e/4 y 6. Vedado, ZC:10400, Havana, Cuba

Telephone:

+53-52833178

+53-52930683

Email:

jorgeluishernandezcastro52@gmail.com

miguel.sarduy@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

15/09/2026

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000471

Date of Registration in Primary Registry:

26/02/2026

Record Verification Date:

2026/02/26

Next update date:

2027/02/26

Link to the spanish version:

Click here [4]