Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-04 @ 5:33 PM
Study NCT ID:
NCT06480604
Status:
RECRUITING
Last Update Posted:
2024-11-07
First Post:
2024-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Multi-strain Probiotic on Recurrent Vulvovaginal Candidiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002181', 'term': 'Candidiasis, Vulvovaginal'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D014848', 'term': 'Vulvovaginitis'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014847', 'term': 'Vulvitis'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-05', 'studyFirstSubmitDate': '2024-06-25', 'studyFirstSubmitQcDate': '2024-06-25', 'lastUpdatePostDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Influence of multi-strain probiotic on vaginal microbiome as compared to baseline and placebo.', 'timeFrame': 'Day 0, Day 90, Day 180', 'description': 'Effects of a multi-strain probiotic in vaginal microbiome as assessed by shotgun analysis and compared to baseline and placebo.'}], 'primaryOutcomes': [{'measure': 'Incidence of culture-confirmed VVC recurrence between baseline and day 180 as compared to placebo.', 'timeFrame': 'Day 0, Day 180', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Occurrence of culture-confirmed VVC recurrence between baseline and day 90 as compared to placebo.', 'timeFrame': 'Day 0, Day 90', 'description': '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.'}, {'measure': 'Time to first recurrence of VVC episode from baseline between probiotic and placebo groups.', 'timeFrame': 'Day 0 to first VVC recurrence', 'description': '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.'}, {'measure': 'Change in the number of days with VVC episode between probiotic and placebo groups.', 'timeFrame': 'Duration (days) of VVC episodes, Day 0-180.', 'description': '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.'}, {'measure': 'Change in severity of VVC episodes between probiotic and placebo groups.', 'timeFrame': 'During VVC episodes', 'description': '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.\n\nThe 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.'}, {'measure': 'Proportion of Candida albicans positive VVC episodes vs other pathogens between probiotic and placebo groups.', 'timeFrame': 'During VVC episodes', 'description': 'Efficacy of a multi-strain probiotic on proportion of Candida albicans positive VVC episodes vs other pathogens.'}, {'measure': 'Number of administrations of vaginal pessaries during acute VVC episodes as compared to baseline and placebo.', 'timeFrame': 'During VVC episodes', 'description': '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.'}, {'measure': 'Changes in vaginal health as assessed by vaginal pH and compared to baseline and placebo.', 'timeFrame': 'Day 0, Day 90, Day 180', 'description': 'Changes in vaginal health as assessed by vaginal pH, compared to baseline and placebo, using pH strips.'}, {'measure': 'Changes in vaginal microbiology as assessed by vaginal Candida albicans culture and compared to baseline and placebo.', 'timeFrame': 'During episodes', 'description': 'Changes in vaginal microbiology as assessed by vaginal Candida albicans culture and compared to baseline and placebo.'}, {'measure': 'Quality of life as assessed using SF-36 and compared to baseline and placebo.', 'timeFrame': 'Day 0, Day 90, Day 180', 'description': 'Changes in quality of life as assessed using SF-36 and compared to baseline and placebo.\n\nTotal 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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microbiome', 'Probiotic', 'Recurrent', 'Vulvovaginal', 'Candidiasis', 'RVVC', 'Vaginal', 'Chronic', 'Infection'], 'conditions': ['Vulvovaginal Candidiasis']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Premenopausal women aged 18-50 years, with a culture-confirmed active VVC episode caused by Candida spp. (albicans or non-albicans) and reported within 24-48 hours of evidence of clinical symptoms.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nIndividuals meeting ALL of the following criteria will be enrolled for the study:\n\n1. Premenopausal women aged 18-50 years.\n2. Women with a culture-confirmed active episode caused by Candida spp. (albicans or non-albicans) reported within 24-48 hours of evidence of clinical symptoms. (No medications should have been initiated before the sample for culture is collected).\n3. Documented history of recurrence of at least 3 VVC episodes in the last 12 months confirmed by vaginal culture /clinical diagnosis.\n4. Culture growth of Candida spp. causing VVC.\n5. Random Capillary Blood Glucose of \\< 110mg/dl.\n6. Willingness to consume the study products for the entire study duration.\n7. Willing to complete all study procedures and comply with study requirements.\n8. Willing to abstain from other supplements or medication.\n9. Ready to give voluntary, written, informed consent to participate in the study.\n\nExclusion Criteria:\n\nIndividuals meeting ANY of the following criteria will be excluded from the study:\n\n1. Post-menopausal and peri-menopausal women.\n2. Pregnant/breast-feeding women.\n3. Use of oral or vaginal anti-fungal medication in the last 14 days.\n4. Vaginal culture suggestive of bacterial vaginosis (Nugent's score of 7-10), trichomonas vaginalis or Gardnerella vaginalis.\n5. Participants found positive for Clotrimazole resistance, by vaginal culture \\& sensitivity at screening.\n6. Known allergy to Clotrimazole.\n7. Women not willing to use any form of vaginal medication during the study.\n8. Use of vaginal douching.\n9. Unwillingness to use an appropriate method of contraception.\n10. Diagnosed with compromised immune system, type I and/or type II diabetes mellitus, or malignancies.\n11. Use of corticosteroids therapy in the last 30 days.\n12. Use of oral/systemic antimicrobial therapy in the last 30 days.\n13. Known allergy to the study products or azoles.\n14. Individuals with a history of frequent infections requiring antibiotic treatments.\n15. Participation in another clinical study(ies) in the last 3 months.\n16. Women who, in the opinion of the Investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the study.\n17. Women with uncontrolled hypertension with systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg.\n18. Heavy alcohol drinkers defined as follows: For men, consuming more than 4 drinks on any day or more than 14 drinks/week. For women, consuming more than 3 drinks on any day or more than 7 drinks/week.\n19. Smokers.\n20. History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders that, in the judgment of the Investigator, would interfere with the participant's ability to provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the individual at undue risk.\n21. Presence of unstable, acutely symptomatic, or life-limiting illness.\n22. Use of any supplements (includes probiotics, post-biotics, herbal supplements, synbiotics, enzyme supplements, vitamins with probiotics) in the last 30 days."}, 'identificationModule': {'nctId': 'NCT06480604', 'acronym': 'PROVELIA', 'briefTitle': 'Effect of a Multi-strain Probiotic on Recurrent Vulvovaginal Candidiasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'The Archer-Daniels-Midland Company'}, 'officialTitle': 'A Pilot Clinical Trial Assessing the Effect of a Multi-strain Probiotic on the Risk of Recurrence and Severity of Symptoms in Females With Recurrent Vulvovaginal Candidiasis', 'orgStudyIdInfo': {'id': 'CTB2022TN202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic', 'description': '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.', 'interventionNames': ['Dietary Supplement: Probiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants in this arm will receive an equivalent placebo for the duration of the study (6 months).', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Probiotic']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants in this arm will receive an equivalent placebo for the duration of the study (6 months).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vadodara', 'state': 'Gujarat', 'status': 'RECRUITING', 'country': 'India', 'facility': 'Anand Multispeciality Hospital', 'geoPoint': {'lat': 22.29941, 'lon': 73.20812}}, {'city': 'Nashik', 'state': 'Maharashtra', 'status': 'RECRUITING', 'country': 'India', 'facility': 'Life Care Hospital', 'geoPoint': {'lat': 19.99727, 'lon': 73.79096}}, {'city': 'Pune', 'state': 'Maharashtra', 'status': 'RECRUITING', 'country': 'India', 'facility': "AMF's Moraya Multispeciality Hospital", 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'city': 'Pune', 'state': 'Maharashtra', 'status': 'RECRUITING', 'country': 'India', 'facility': 'ENT & Vertigo Clinic', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'city': 'Sopāra', 'state': 'Maharashtra', 'status': 'RECRUITING', 'country': 'India', 'facility': 'Vivaan Hospital', 'geoPoint': {'lat': 19.36421, 'lon': 76.18205}}, {'city': 'Vasai', 'state': 'Maharashtra', 'status': 'RECRUITING', 'country': 'India', 'facility': "Matritva Women's Hospital", 'geoPoint': {'lat': 20.50215, 'lon': 75.66459}}], 'centralContacts': [{'name': 'ADM Medical Team', 'role': 'CONTACT', 'email': 'medical@protexin.com', 'phone': '+441460243230'}, {'name': 'Sanjay Dr Vaze, MBBS, MD', 'role': 'CONTACT', 'email': 'sanjay.v@vediclifesciences.com', 'phone': '+9102242172325'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Archer-Daniels-Midland Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Vedic Lifesciences Pvt. Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}