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

Not Applicable

Completed

• Conditions: Vaginal Health; Women's Health
• Interventions: Dietary Supplement: Good Girl Probiotics

• Registration Number: NCT06506357
• Lead Sponsor: Love Wellness

Brief Summary

This virtual single-group clinical trial aims to evaluate the effects of the Good Girl Probiotics supplement on vaginal health. Participants will take one capsule of the probiotic supplement daily for eight weeks. They will complete questionnaires at Baseline, after the first dose, and at the end of Weeks 2, 4, 6, and 8 to assess changes in vaginal pH, vaginal health, and urinary tract health.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-24
• Primary Completion: 2024-06-24
• Study Completion: 2024-06-24
• Status Verified: 2024-07
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-11
• Last Update Submitted: 2024-07-11
• Study First Posted: 2024-07-17
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

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

Inclusion Criteria

• Female at birth.
• Aged 18+.
• Interested in supporting a balanced vaginal pH, vaginal health, and urinary tract health.
• Regularly experience symptoms of an unbalanced vagina, including an atypical smell, discharge, itching, swelling, irritation, pain during sex, and/or burning sensation while urinating.
• Willing to avoid using products or medications that target vaginal or urinary tract health infections.
• Willing to avoid other probiotics.
• Able to follow the study protocol.

Exclusion Criteria

• Two or more bladder infections in six months or three or more infections in a year.
• Recent surgeries or invasive treatments within the last six months.
• Use of products or medications targeting vaginal or urinary tract health in the last 12 weeks.
• Known allergies to the product ingredients.
• Chronic health conditions impacting participation.
• Pregnant, breastfeeding, or trying to conceive.
• History of substance abuse.
• Current or former smoker within the past six months.
• Participation in another clinical trial.
• Diagnosed vaginal or pelvic conditions.
• Use of vaginal-related birth control (NuvaRing, IUD).
• Changes in hormonal birth control in the last three months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Probiotic Supplement Group	Good Girl Probiotics	Participants in this group will receive the Good Girl Probiotics supplement.

Primary Outcome Measures

Name	Time	Method
Vaginal and Urinary Tract Health and Balance	Baseline, Week 2, Week 4, Week 6, Week 8	Assessment of vaginal and urinary tract health and balance through questionnaires completed by participants at Baseline, after the first dose, and at the end of Weeks 2, 4, 6, and 8.

Secondary Outcome Measures

Name	Time	Method
Vaginal Environment and Odor	Baseline, Week 2, Week 4, Week 6, Week 8	Assessment of the vaginal environment and odor through questionnaires completed by participants at Baseline, after the first dose, and at the end of Weeks 2, 4, 6, and 8.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States