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

NCT06565312 | Completed

• 1 other identifier: 20434
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Health; Vaginal pH

Keywords

Vaginal suppository; Women's Health

Outcome Measures

Primary Outcomes (2)

• Effect on Vaginal pH and Health

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

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

• Effect on Vaginal pH and Health

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

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

Secondary Outcomes (1)

• Participant Perception of Vaginal Freshness and Odor

  Baseline, Day 2, Day 5

Study Arms (1)

Flora Power Probiotic Vaginal Suppository

EXPERIMENTAL

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.

Dietary Supplement: Flora Power Probiotic Vaginal Suppository

Interventions

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.

Flora Power Probiotic Vaginal Suppository

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Love Wellness: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: August 21, 2024
• Study Start: May 10, 2024
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)