Effect of a Multi-strain Probiotic on Recurrent Vulvovaginal Candidiasis

NCT06480604 | Recruiting

• 1 other identifier: CTB2022TN202
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 6

Brief 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).

Conditions

Vulvovaginal Candidiasis

Keywords

Microbiome; Probiotic; Recurrent; Vulvovaginal; Candidiasis; RVVC; Vaginal; Chronic; Infection

Outcome Measures

Primary Outcomes (1)

• Incidence of culture-confirmed VVC recurrence between baseline and day 180 as compared to placebo.

  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.

  Day 0, Day 180

Secondary Outcomes (9)

• Occurrence of culture-confirmed VVC recurrence between baseline and day 90 as compared to placebo.

  Day 0, Day 90

• Time to first recurrence of VVC episode from baseline between probiotic and placebo groups.

  Day 0 to first VVC recurrence

• Change in the number of days with VVC episode between probiotic and placebo groups.

  Duration (days) of VVC episodes, Day 0-180.

• Change in severity of VVC episodes between probiotic and placebo groups.

  During VVC episodes

• Proportion of Candida albicans positive VVC episodes vs other pathogens between probiotic and placebo groups.

  During VVC episodes

Other Outcomes (1)

• Influence of multi-strain probiotic on vaginal microbiome as compared to baseline and placebo.

  Day 0, Day 90, Day 180

Study Arms (2)

Probiotic

EXPERIMENTAL

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.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Participants in this arm will receive an equivalent placebo for the duration of the study (6 months).

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

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.

Probiotic

Placebo DIETARY_SUPPLEMENT

Participants in this arm will receive an equivalent placebo for the duration of the study (6 months).

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Premenopausal women aged 18-50 years, with a culture-confirmed active VVC episode caused by Candida spp. (albicans or non-albicans) and reported within 24-48 hours of evidence of clinical symptoms.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals meeting ALL of the following criteria will be enrolled for the study:
• Premenopausal women aged 18-50 years.
• 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).
• Documented history of recurrence of at least 3 VVC episodes in the last 12 months confirmed by vaginal culture /clinical diagnosis.
• Culture growth of Candida spp. causing VVC.
• Random Capillary Blood Glucose of \< 110mg/dl.
• Willingness to consume the study products for the entire study duration.
• Willing to complete all study procedures and comply with study requirements.
• Willing to abstain from other supplements or medication.
• Ready to give voluntary, written, informed consent to participate in the study.

You may not qualify if:

• Individuals meeting ANY of the following criteria will be excluded from the study:
• Post-menopausal and peri-menopausal women.
• Pregnant/breast-feeding women.
• Use of oral or vaginal anti-fungal medication in the last 14 days.
• Vaginal culture suggestive of bacterial vaginosis (Nugent's score of 7-10), trichomonas vaginalis or Gardnerella vaginalis.
• Participants found positive for Clotrimazole resistance, by vaginal culture \& sensitivity at screening.
• Known allergy to Clotrimazole.
• Women not willing to use any form of vaginal medication during the study.
• Use of vaginal douching.
• Unwillingness to use an appropriate method of contraception.
• Diagnosed with compromised immune system, type I and/or type II diabetes mellitus, or malignancies.
• Use of corticosteroids therapy in the last 30 days.
• Use of oral/systemic antimicrobial therapy in the last 30 days.
• Known allergy to the study products or azoles.
• Individuals with a history of frequent infections requiring antibiotic treatments.

Sponsors & Collaborators

• The Archer-Daniels-Midland Company: lead
• Vedic Lifesciences Pvt. Ltd.: collaborator

Study Sites (6)

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

MeSH Terms

Conditions

Candidiasis, Vulvovaginal; Recurrence; Candidiasis; Bronchiolitis Obliterans Syndrome; Infections

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

ADM Medical Team

CONTACT

+441460243230; medical@protexin.com

Sanjay Dr Vaze, MBBS, MD

CONTACT

+9102242172325; sanjay.v@vediclifesciences.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: June 28, 2024
• Study Start: October 15, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (6)