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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
105
Capsule containing active form of dietary supplement
Capsule containing placebo
Bonafide Health
Harrison, New York, United States
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.'
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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