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

Not Applicable

Completed

• Conditions: Vaginal Health; Vaginal pH
• Interventions: Dietary Supplement: Flora Power Probiotic Vaginal Suppository

• Registration Number: NCT06565312
• Lead Sponsor: Love Wellness

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-10
• Primary Completion: 2024-07-10
• Study Completion: 2024-07-10
• Study First Submitted: 2024-07-11
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-21
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Flora Power Probiotic Vaginal Suppository	Flora Power Probiotic Vaginal Suppository	Participants will use the Flora Power suppository once daily at bedtime for 5 consecutive days when they feel they are experiencing any of the common signs of vaginal imbalance like vaginal malodor, vaginal irritation, and/or vaginal itching.

Primary Outcome Measures

Name	Time	Method
Effect on Vaginal pH and Health	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 Outcome Measures

Name	Time	Method
Participant Perception of Vaginal Freshness and Odor	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.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States