The Effects of an Orally-Administered Probiotic on Vaginal Symptoms

NCT07829861 | Completed

• 2 other identifiers: BH-CLV-BT-00114112
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, double-blind, placebo-controlled, virtual trial is designed to determine the efficacy of an orally-administered probiotic on alleviating vaginal odor and other vaginal symptoms. Eligibility is determined by the presence of vaginal symptoms. Participation in the trial lasts approximately 75 days; during 15 of these days, participants consume a capsule containing the active form of the probiotic or a placebo. Participants complete weekly questionnaires with items pertaining to their subjective vaginal health as well as a daily diary during participation.

Conditions

Vaginal Odor

Keywords

vaginal health; vaginal odor; vaginal discharge; vaginal irritation; vaginal itching; vaginal microbiome

Outcome Measures

Primary Outcomes (2)

• Vaginal odor frequency

  Change in self-reported vaginal odor frequency across weekly timepoints and between groups during the intervention period as measured by the internally-developed 8-point Vaginal Odor Frequency Scale, where 0= 0 days (Never) and 7= 7 days (Every day).

  From Baseline to the end of Intervention Period at Week 4

• Vaginal odor severity

  Change in self-reported vaginal odor severity across weekly timepoints and between groups during the intervention period as measured by the internally-developed 6-point Vaginal Odor Severity Scale, where 0= Absent and 5= Very Severe.

  From Baseline to the end of Intervention Period at Week 4

Secondary Outcomes (4)

• Vaginal odor bothersomeness

  From Baseline to the end of Intervention Period at Week 4

• Vaginal symptoms as measured by the vulvovaginal symptoms questionnaire (VSQ)

  From Baseline to Week 4 of the Intervention Period

• Vaginal Odor Buden Index (OBI)

  From Baseline to the end of Intervention Period at Week 4

• Good vs Bad Vaginal Odor Days

  Daily from Baseline to Week 4 during the Intervention Period

Other Outcomes (3)

• Vaginal Odor-Related Quality of Life (QOL)

  Every other week from Baseline to Week 4 of the Intervention Period

• Impression of change in vaginal odor

  Measured once at Week 4 of the Intervention Period

• Product Satisfaction

  Once at Week 4 of the Intervention Period

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Capsule containing placebo

Dietary Supplement: Placebo

Active

ACTIVE COMPARATOR

Capsule containing active probiotic supplement

Dietary Supplement: Orally-administered probiotic

Interventions

Orally-administered probiotic DIETARY_SUPPLEMENT

Capsule containing active form of dietary supplement

Active

Placebo DIETARY_SUPPLEMENT

Capsule containing placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy women who are 18-65 years of age (inclusive).
• Have a body mass index (BMI) between 18.5 to 29.9 kg/m2 (inclusive).
• Experiences vaginal odor.
• Maintains study eligibility status during the run-in period (as outlined during the pre-screening period) from screening through the end of the study.
• Have no current medical diagnosis of active bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), or urinary tract infection (UTI), or any other active infectious, inflammatory, or neoplastic vulvovaginal or genitourinary disorder.
• Have not been medically diagnosed with recurrent BV as defined by 3 or more diagnosed infections in the past 12 months, recurrent VVC as defined by 3 or more symptomatic, diagnosed infections in the past 12 months, or recurrent UTIs as defined by 3 or more diagnosed infections in the past year or 2 or more diagnosed infections in the past 6 months.
• In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
• Willing to report information related to your menstrual cycle and menopause status.
• Agree to refrain from using probiotic/prebiotic supplements (oral or vaginal); boric acid; pH-balancing tampons, pads, wipes, and washes; antifungals (oral or vaginal); antibiotics, and other treatments listed in Section 6.5 during the defined timeframe.
• Agree to refrain from making changes to current level of consumption of foods containing probiotics/prebiotics.
• Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.

You may not qualify if:

• Active infectious, inflammatory, or neoplastic vulvovaginal or genitourinary disorder (such as vulvovaginal candidiasis, bacterial vaginosis, urinary tract infection, vulvar intraepithelial neoplasia, or lichen sclerosis).
• Symptomatic sexually transmitted infection.
• Use of probiotics within the past 3 months.
• Any prior use of intervention product.
• Use of antibiotics within the past 3 months.
• Vaginal hormone therapy (unless dosage and modality has been stable for 90 days prior to enrollment).
• Current use of any medications, supplements, or over-the-counter remedies (including boric acid and deodorants) for vaginal odor.
• Vaginal rinses, moisturizers, cooling devices, cooling mattresses, or cooling sprays (unless habitually used for at least 90 days prior to enrollment).
• Self-reported urinary incontinence.
• Currently lactating, pregnant, or planning to become pregnant during the study period.
• Known sensitivity, intolerability, or allergy to any of the study products or their ingredients.
• Any clinically significant disease or disorder which, in the opinion of the study investigator, may place you at undue risk or harm, interfere with ability to participate, compromise the interpretability of the study data.
• History of alcohol or substance abuse in the last 5 years.
• History of smoking in the last 2 years.
• Currently participating in another clinical research study on vulvovaginal health.

Sponsors & Collaborators

• Bonafide Health: lead

Study Sites (1)

Bonafide Health

Harrison, New York, 10528, 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: July 29, 2025
• Primary Completion: January 22, 2026
• Study Completion: January 22, 2026
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)