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

NCT ID: NCT06565312

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-10

Study Completion Date

2024-07-10

Brief Summary

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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

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Conditions

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Vaginal Health Vaginal pH

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Flora Power Probiotic Vaginal Suppository

Intervention Type 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.

Interventions

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Flora Power Probiotic Vaginal Suppository

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Citruslabs

INDUSTRY

Sponsor Role collaborator

Love Wellness

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Citruslabs

Santa Monica, California, United States

Site Status

Countries

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United States

Other Identifiers

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20434

Identifier Type: -

Identifier Source: org_study_id

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