Randomized, Double-Blind Placebo-Controlled Trial to Assess Overall User Experience of a Synbiotic Vaginal Suppository

Completed · Not applicable · Has a placebo group

Conditions studied: Vaginal Personal Care

In brief

The purpose of this study is to assess the impact of a personal care product on vaginal health in individuals with a self-reported history of vaginal discomforts such as malodor, bothersome discharge, itching, irritation, and dryness. The personal care product, VH-01 contains a prebiotic and three distinct strains of Lactobacillus crispatus, a microbe commonly found in healthy vaginal microbiomes. The study will be a randomized, placebo-controlled trial where the test product will be compared to a placebo in a 2:1 manner. Participants will be asked to complete online questionnaires and provide vaginal samples to assess microbial communities. The aims of this study are to assess: 1. The user experience and acceptability of VH-01 vaginal suppository vs. placebo. 2. Attitudes and perceptions of VH-01 vaginal suppository usage vs. placebo. 3. Health-related quality of life during the use of VH-01 vaginal suppository vs. placebo. 4. Changes in self-perceived vaginal discomforts during the use of VH-01 vaginal suppository vs. placebo.

Key facts

Study ID: NCT06236893
Run by: Seed Health
People needed: 200
Starts: 2024-01-29
Expected to finish: 2024-07-31
Last updated by the study team: 2025-05-31

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Individuals with a vagina 18 - 55 years old at time of electronic consent
Sex assigned female at birth
Self-reported history of any of the following vaginal discomforts occurring recently and regularly, including but not limited to: Vaginal malodor, Bothersome vaginal discharge, Vaginal itching, Vaginal irritation, Vaginal dryness
Willing to use an intra-vaginal suppository during the study and not knowing the product identity (active or placebo)
Willing to complete questionnaires, which include questions related to vaginal health and sexual history/behavior
Able to read and comprehend English and provide written informed consent
Have reliable access to the internet

You may not qualify if…

In menopause or experiencing menopausal symptoms
History of irregular menses; defined as less than 25 day or more than 35 day cycle or length of time between cycles varies by more than 9 days
Planned insertion or replacement of IUD in next 3 months (if applicable)
Active pelvic or vaginal infection (i.e., active urinary tract infection, active bacterial vaginosis, active yeast infection). NOTE: Eligible to re-screen 4 weeks after completion of treatment for an active infection.
Current or anticipated oral or vaginal antibiotic/antifungal treatment in the next 3 months (e.g., preoperative antibiotics for upcoming elective procedure). NOTE: Eligible to re-screen 4-weeks after completion of treatment
Unwilling to discontinue the use of specified intra-vaginal products during the study including the following: vaginal probiotic suppositories, vaginal moisturizers, boric acid suppositories, pH balancing wipes, intravaginal gel, external vaginal itch relief cream, odor control sprays, vaginal steam products, vaginal cleansing douche, feminine/vaginal cleanser, vaginal preventive deodorant, gel/cream treatments for feminine odor
Orally administered probiotics for vaginal health. NOTE: Oral probiotics for non-vaginal conditions (e.g., gastrointestinal health) are permitted. Eligible to re-screen 1-week after discontinuing orally administered probiotics for vaginal health
Pregnant, breastfeeding or trying to conceive during the course of the study
Active abnormal uterine/vaginal bleeding
Receiving chronic oral steroid therapy (excluding those for skin, eyes, nose, or inhaled) or have received such therapy within 4 weeks of screening
Surgery, immunotherapy, chemotherapy, radiation or biological cancer therapy within 30 days of enrollment and/or planned during the next 3 months
Allergy to any components of the supporting or excipient ingredients in test formulation tablets/placebo
Active serious medical condition requiring current treatment including but not limited to: Cancer, Autoimmune diseases (lupus, rheumatoid arthritis, Crohn's disease), Chronic infections (e.g., HIV, Hepatitis B, Hepatitis C), Serious cardiac, liver, or kidney disease, Psychiatric conditions/substance use disorders,
Any condition which in the investigator's opinion may jeopardize the individual's safety or interfere with the ability to comply with the study
Lives in the state of Alaska, Louisiana, New Jersey or New York

Where it is running

Citruslabs — Santa Monica, California, United States

Full record on ClinicalTrials.gov

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