An interventional study of Orally-administered probiotic and Placebo in Vaginal Odor, sponsored by Bonafide Health. Completed at 1 site in United States. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Bonafide Health (part of Otsuka Holdings Co., Ltd.) · Not applicable, Interventional, and Supportive care
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.
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 on women who experience vaginal odor and are otherwise healthy. Eligibility is determined by the presence of vaginal symptoms. Participation in the trial lasts approximately 75 days. Preceding intervention, there is a 7-day run-in period. Participants who surpass the run-in period take a dose of the orally-administered study product (active or placebo) once daily for 15 days, which is followed by a 15-day off-treatment period. Participants complete weekly questionnaires and daily diaries with items pertaining to their subjective vaginal health during the run-in and intervention periods. Participants then enter into a 30-day washout period, ending with the completion of one final questionnaire.
21 studies on the registry are indexed under Vaginal Discharge; 2 are open to participants now.
This study's enrollment of 105 is below the median of 127 across 16 interventional studies indexed under Vaginal Discharge.
Browse Vaginal Discharge studies →Bonafide Health is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
First submitted after Bonafide Health became part of Otsuka Holdings Co., Ltd..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Capsule containing placebo
Dietary Supplement: Placebo
Capsule containing active probiotic supplement
Dietary Supplement: Orally-administered probiotic
Capsule containing active form of dietary supplement
Capsule containing placebo
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).
Time frame: 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.
Time frame: From Baseline to the end of Intervention Period at Week 4
Vaginal odor bothersomeness
Change in self-reported vaginal odor bothersomeness across weekly timepoints and between groups during the intervention period as measured by the internally-developed 6-point Vaginal Odor Bothersomeness Scale, where 0= Not Bothersome At All and 5= Extremely Bothersome.
Time frame: From Baseline to the end of Intervention Period at Week 4
Vaginal symptoms as measured by the vulvovaginal symptoms questionnaire (VSQ)
Change in self-reported vaginal health symptoms across weekly timepoints and between groups during the intervention period as measured by the clinically-validated vulvovaginal symptoms questionnaire (VSQ). The VSQ includes 21 binary (i.e., Yes/No) questions pertaining to vaginal health and its impact on daily life.
Time frame: From Baseline to Week 4 of the Intervention Period
Vaginal Odor Buden Index (OBI)
Vaginal Odor Buden Index (OBI) is the calculated product of weekly Vaginal Odor Severity and Vaginal Odor Frequency scores during the intervention period. Vaginal OBI score can range from 0-35 (as a product of the 0-5 Vaginal Odor Severity scale and 0-7 Vaginal Odor Frequency scale), with 0 classified as 'None,' 1-8 classified as 'Mild,' 9-20 classified as 'Moderate,' and 21-35 classified as 'Severe.'
Time frame: From Baseline to the end of Intervention Period at Week 4
Good vs Bad Vaginal Odor Days
The proportion of "good" odor days, which is defined as the change in self-reported ratio of "good", "neither bad nor good", and "bad" vaginal odor days across daily timepoints and between groups during the intervention period. Participants select whether they categorize the past 24 hours as a "good", "neither bad nor good", or "bad" vaginal odor day each day.
Time frame: Daily from Baseline to Week 4 during the Intervention Period
Vaginal Odor-Related Quality of Life (QOL)
Change in and between-group differences in vaginal odor-related quality of life (QOL), as assessed every other week by the internally-developed Vaginal Odor-Related QOL evaluating impact of vaginal odor on daily functioning, well-being, and social or intimate relationships. The questionnaire includes 10 items that are answered on a 4-point Likert-type scale with responses ranging from 'Not at all' to 'A lot'.
Time frame: Every other week from Baseline to Week 4 of the Intervention Period
Impression of change in vaginal odor
Impression of change in vaginal odor between groups, as measured by the validated Patient Global Impression of Change (PGIC) scale, completed at Week 4 of the Intervention Period. The PGIC is a 1-item, 7-point scale assessing self-reported improvement, where 1= Very Much Improved and 7= Very Much Worse.
Time frame: Measured once at Week 4 of the Intervention Period
Product Satisfaction
Difference between groups in product satisfaction assessed through an internally-developed Product Experience Questionnaire (PEQ) with items measured on a 4-point scale ranging from Strongly Disagree to Strongly Agree. The PEQ is administered once at Week 4 of the Intervention Period.
Time frame: Once at Week 4 of the Intervention Period
Plan to share: No — Single site
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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