A Study to Evaluate the Effects of a Prebiotic and Probiotic Supplement to Provide Relief From Symptoms Associated With Bacterial Vaginosis and Yeast Infections.

Happy V

Status: Not yet enrolling

Conditions: Yeast Infection; Bacterial Vaginosis

Treatments: Dietary Supplement: Excipient Placebo Supplement; Dietary Supplement: Active Placebo Supplement; Dietary Supplement: Prebiotic + Probiotic Supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT06665126

20397

Details and patient eligibility

About

This virtual randomized controlled trial evaluates the efficacy of a prebiotic and probiotic supplement in providing relief from symptoms associated with bacterial vaginosis and yeast infections. Participants will be randomized into three groups-test product, active placebo, and excipient placebo-and will take two capsules daily for 30 days. The study will assess the effects on vaginal microbiome, symptoms of bacterial vaginosis and yeast infections, and overall vaginal health.

Enrollment: 120 estimated patients

Sex: Female

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women
• Age 25+
• Self-reported concerns symptoms associated with bacterial vaginosis or candida overgrowth, including itchiness, redness, abnormal discharge, and an unpleasant odor.
• Suffers from digestive issues, including bloating, gas, or other digestive discomfort.
• Generally healthy - do not live with any uncontrolled chronic diseases.
• Willing to avoid using any vaginal health-related medications, supplements, and herbal remedies for the duration of this study.
• If taking oral supplements or herbal remedies targeted at vaginal health, has been consistently taking these for at least 3 months prior to starting the study and is willing to maintain this routine for the study duration.

Exclusion criteria

• Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
• Planning to undergo any procedure related to their vaginal health.
• Started any new medications or supplements that target vaginal health in the past 3 months.
• Anyone with known severe allergic reactions that require the use of an Epi-Pen, or any known allergies to any of the product ingredients
• Women who are pregnant, breastfeeding, or attempting to conceive
• Unwilling to follow the study protocol
• Anyone who has undergone any surgeries or invasive treatments in the last three months or has any planned during the study period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups, including a placebo group

Test Product Group

Experimental group

Description:

Participants in this group will receive the test product, a prebiotic and probiotic supplement.

Treatment:

Dietary Supplement: Prebiotic + Probiotic Supplement

Active Placebo Group

Placebo Comparator group

Description:

Participants in this group will receive an active placebo.

Treatment:

Dietary Supplement: Active Placebo Supplement

Excipient Placebo Group

Placebo Comparator group

Description:

Participants in this group will receive an excipient placebo.

Treatment:

Dietary Supplement: Excipient Placebo Supplement