An interventional study of Probiotic and Placebo in Vulvovaginal Candidiasis, sponsored by The Archer-Daniels-Midland Company. Recruiting at 6 sites in India. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-07.
Sponsored by The Archer-Daniels-Midland Company · Not applicable, Interventional, and Prevention
This study evaluates the effect of a multi-strain probiotic on the risk of recurrence and severity of symptoms in females with recurrent vulvovaginal candidiasis (R-VVC).
This study aims to investigate the efficacy of live bacteria on the incidence and severity of symptoms of vulvovaginal candidiasis (VVC) recurrence. The trial will be run in India and recruit women with recurrent vulvovaginal candidiasis (R-VVC).
109 studies on the registry are indexed under Candidiasis, Vulvovaginal; 14 are open to participants now.
This study's planned enrollment of 126 is close to the median of 126 across 91 interventional studies indexed under Candidiasis, Vulvovaginal.
Browse Candidiasis, Vulvovaginal studies →The Archer-Daniels-Midland Company is the lead sponsor of 19 studies on the registry; 6 are open to participants now.
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.
Individuals meeting ALL of the following criteria will be enrolled for the study:
Exclusion Criteria:
Individuals meeting ANY of the following criteria will be excluded from the study:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Participants in this arm will receive a daily dose of 2x10\^9 Colony Forming Units (CFU) of a multi strain probiotic (live bacterium), corresponding to 2 capsules once daily, for 6 months.
Dietary Supplement: Probiotic
Participants in this arm will receive an equivalent placebo for the duration of the study (6 months).
Dietary Supplement: Placebo
Participants in this arm will receive a daily dose of 2x10\^9 Colony Forming Units (CFU) of a multi strain probiotic (live bacterium), corresponding to 2 capsules once daily, for 6 months.
Participants in this arm will receive an equivalent placebo for the duration of the study (6 months).
Incidence of culture-confirmed VVC recurrence between baseline and day 180 as compared to placebo.
Efficacy of a multi-strain probiotic on incidence of culture-confirmed VVC recurrence as compared to placebo, where VVC recurrence is defined as a fungal culture positive vaginal swab with at least 2 moderate VVC related symptoms or at least 1 severe VVC related symptom and with VVC free period prior to this incident of at least 7 days.
Time frame: Day 0, Day 180
Occurrence of culture-confirmed VVC recurrence between baseline and day 90 as compared to placebo.
Efficacy of a multi-strain probiotic on incidence of culture-confirmed VVC recurrence as compared to placebo, where VVC recurrence is defined as a fungal culture positive vaginal swab with at least 2 moderate VVC related symptoms or at least 1 severe VVC related symptom and with VVC free period prior to this incident of at least 7 days.
Time frame: Day 0, Day 90
Time to first recurrence of VVC episode from baseline between probiotic and placebo groups.
Time to first recurrence of VVC episode from baseline between probiotic and placebo groups, where VVC recurrence is defined as a fungal culture positive vaginal swab with at least 2 moderate VVC related symptoms or at least 1 severe VVC related symptom and with VVC free period prior to this incident of at least 7 days.
Time frame: Day 0 to first VVC recurrence
Change in the number of days with VVC episode between probiotic and placebo groups.
Efficacy of a multi-strain probiotic on the number of days with VVC episode as compared to placebo group, where VVC episode is defined as a fungal culture positive vaginal swab with at least 2 moderate VVC related symptoms or at least 1 severe VVC related symptom and with VVC free period prior to this incident of at least 7 days.
Time frame: Duration (days) of VVC episodes, Day 0-180.
Change in severity of VVC episodes between probiotic and placebo groups.
Efficacy of a multi-strain probiotic on the severity of VVC episodes as assessed by symptoms (itching/soreness, edema, dysuria, vaginal discharge, dyspareunia, erythema, fissures/excoriations) severity on a 4-point Likert Scale as compared to baseline and placebo. The number of days of an episode will be captured using the e-dairy. First day of the episode will be considered as the day when the participant experiences onset of at least 2 moderate symptoms or at least one severe symptom on the 4-point Likert scale. The last day of the episode will be considered when there is no presence of VVC related clinical signs and symptoms and thus the composite score on the Likert scale is 0.
Time frame: During VVC episodes
Proportion of Candida albicans positive VVC episodes vs other pathogens between probiotic and placebo groups.
Efficacy of a multi-strain probiotic on proportion of Candida albicans positive VVC episodes vs other pathogens.
Time frame: During VVC episodes
Number of administrations of vaginal pessaries during acute VVC episodes as compared to baseline and placebo.
Number of vaginal pessaries applied during acute VVC episodes as compared to baseline and placebo. A Clotrimazole 100 mg pessary to be applied once daily at bedtime till no symptoms persist.
Time frame: During VVC episodes
Changes in vaginal health as assessed by vaginal pH and compared to baseline and placebo.
Changes in vaginal health as assessed by vaginal pH, compared to baseline and placebo, using pH strips.
Time frame: Day 0, Day 90, Day 180
Changes in vaginal microbiology as assessed by vaginal Candida albicans culture and compared to baseline and placebo.
Changes in vaginal microbiology as assessed by vaginal Candida albicans culture and compared to baseline and placebo.
Time frame: During episodes
Quality of life as assessed using SF-36 and compared to baseline and placebo.
Changes in quality of life as assessed using SF-36 and compared to baseline and placebo. Total and individual scoring of the 8 sections of the SF-36 questionnaire will be used to infer the improvement in quality of life improve. A high score defines a more favorable health state (maximum score 100).
Time frame: Day 0, Day 90, Day 180
Influence of multi-strain probiotic on vaginal microbiome as compared to baseline and placebo.
Effects of a multi-strain probiotic in vaginal microbiome as assessed by shotgun analysis and compared to baseline and placebo.
Time frame: Day 0, Day 90, Day 180
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Jul 2025, 9 months after the start.
Of 20 interventional studies with no phase under Candidiasis, Vulvovaginal, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's planned 9 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Probiotic
The Archer-Daniels-Midland Company