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

NCT06236893 | Completed

• 1 other identifier: 20260
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.The user experience and acceptability of VH-01 vaginal suppository vs. placebo.
2. 2.Attitudes and perceptions of VH-01 vaginal suppository usage vs. placebo.
3. 3.Health-related quality of life during the use of VH-01 vaginal suppository vs. placebo.
4. 4.Changes in self-perceived vaginal discomforts during the use of VH-01 vaginal suppository vs. placebo.

Conditions

Vaginal Personal Care

Keywords

Lactobacillus crispatus; vaginal malodor; vaginal discharge; vaginal itching; vaginal irritation; vaginal dryness

Outcome Measures

Primary Outcomes (1)

• To evaluate user experience of VH-01 vaginal suppository vs. placebo.

  Self-reported rate of product acceptance to support vaginal health through month 3.

  From enrollment through three complete menstrual cycles or approximately 3 months.

Secondary Outcomes (2)

• To evaluate attitudes and perceptions of VH-01 vaginal suppository usage vs. placebo.

  From enrollment through three complete menstrual cycles or approximately 3 months.

• To evaluate health-related quality of life during the use of VH-01 vaginal suppository vs. placebo.

  From enrollment through three complete menstrual cycles or approximately 3 months.

Other Outcomes (1)

• To evaluate changes in self-perceived vaginal discomforts during the use of VH-01 vaginal suppository vs. placebo.

  From enrollment through three complete menstrual cycles or approximately 3 months.

Study Arms (2)

VH-01 vaginal suppository tablet

EXPERIMENTAL

Participants will be instructed to take VH-01 vaginal suppository tablet (active product) as directed.

Other: VH-01 vaginal suppository tablet

Placebo vaginal suppository tablet

PLACEBO COMPARATOR

Participants will be instructed to take the placebo vaginal suppository tablet as directed. The placebo vaginal suppositories do not contain active ingredients and are identical in appearance to the active product.

Other: Placebo vaginal suppository tablet

Interventions

VH-01 vaginal suppository tablet OTHER

Participants will be instructed to take VH-01 Days 1, 4, 7, 14, and 21 of Month 1 and Days 1 and 14 of Months 2 and 3.

VH-01 vaginal suppository tablet

Placebo vaginal suppository tablet OTHER

Participants will be instructed to take the placebo on Days 1, 4, 7, 14, and 21 of Month 1 and Days 1 and 14 of Months 2 and 3.

Placebo vaginal suppository tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Seed Health: lead

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Vaginal Discharge

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Dirk Gevers, PhD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: January 29, 2024
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)