A Single Group Study to Evaluate the Effects of a Probiotic Supplement on Vaginal Health.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Love Wellness
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Vaginal and Urinary Tract Health and Balance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Probiotic Supplement Group
Participants in this group will receive the Good Girl Probiotics supplement.
Intervention: Good Girl Probiotics (Dietary Supplement)
Outcomes
Primary Outcomes
Vaginal and Urinary Tract Health and Balance
Time Frame: 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 Outcomes
- Vaginal Environment and Odor(Baseline, Week 2, Week 4, Week 6, Week 8)