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OpenTrials
Completed

NCT Number: NCT06506357

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

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.

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Key information

Conditions

Vaginal Health Women's Health

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Good Girl Probiotics

Dietary Supplement

Participants will take one capsule of the Good Girl Probiotics supplement daily in the morning for eight weeks.

Primary outcomes

  1. 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

  1. Vaginal Environment and Odor

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Love Wellness

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 17, 2024
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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