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

NCT06506357 | Completed

• 1 other identifier: 20433
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Health; Women's Health

Keywords

Probiotic Supplement; Urinary Tract Health

Outcome Measures

Primary Outcomes (1)

• Vaginal and Urinary Tract Health and Balance

  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.

  Baseline, Week 2, Week 4, Week 6, Week 8

Secondary Outcomes (1)

• Vaginal Environment and Odor

  Baseline, Week 2, Week 4, Week 6, Week 8

Study Arms (1)

Probiotic Supplement Group

EXPERIMENTAL

Participants in this group will receive the Good Girl Probiotics supplement.

Dietary Supplement: Good Girl Probiotics

Interventions

Good Girl Probiotics DIETARY_SUPPLEMENT

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

Probiotic Supplement Group

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 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.

You may not qualify if:

• 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.

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: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: April 24, 2024
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)