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OpenTrials
Completed

NCT Number: NCT06565312

A Single Group Study to Evaluate the Effects of a Probiotic Vaginal Suppository on Vaginal Health.

This is a virtual single-group clinical trial lasting 8 weeks to evaluate the effects of a probiotic vaginal suppository on vaginal health. Participants will use the Flora Power suppository daily for 5 consecutive days when experiencing common signs of vaginal imbalance. They will complete questionnaires and vaginal pH tests before and after product use.

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Key information

Conditions

Vaginal Health Vaginal pH

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female at birth, aged 18+.
  • Interested in maintaining a healthy vaginal environment.
  • Experience common signs of vaginal imbalance (e.g., malodor, irritation).
  • Willing to avoid other vaginal products and follow study protocol.

Exclusion criteria

  • Recent surgeries or invasive treatments.
  • Use of vaginal health products in the last 12 weeks.
  • Allergies to product ingredients.
  • Chronic health conditions impacting participation.
  • Pregnant, breastfeeding, or trying to conceive.
  • History of substance abuse or smoking.
  • Currently participating in another clinical trial.

Treatment and study plan

Flora Power Probiotic Vaginal Suppository

Dietary Supplement

The suppository contains Microcrystalline Cellulose, Ascorbic Acid, Vitamin C, Gelatin Capsule, Vaginal Probiotic Blend (Lactobacillus fermentum LF61, Lactobacillus acidophilus LA85, Lactobacillus plantarum Lp90), Magnesium Stearate, and Silicon Dioxide.

Primary outcomes

  1. Effect on Vaginal pH and Health

    Time frame: Baseline, Day 6 (24 hours after the last suppository insertion)

    Measure the change in vaginal pH levels with a test strip from baseline to 24 hours after the 5-day intervention period.

  2. Effect on Vaginal pH and Health

    Time frame: Baseline, Day 6 (24 hours after the last suppository insertion)

    Measure the change in overall vaginal health from baseline to 24 hours after the 5-day intervention period with a questionnaire.

Secondary outcomes

  1. Participant Perception of Vaginal Freshness and Odor

    Time frame: Baseline, Day 2, Day 5

    Evaluate participants' perceptions of the vaginal suppository's impact on vaginal freshness and odor, as well as the support of a calm, soothed, and balanced vaginal environment. This outcome measure is assessed with questionnaires.

Sponsors and collaborators

Lead sponsor

Love Wellness

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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