Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
50 participants
INTERVENTIONAL
2024-05-01
2025-06-01
Brief Summary
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Detailed Description
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Samples for the study are: vaginal swab, faecal sample, urine sample.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PreforPro
Preforpro Dosage form - capsule Dosage - participants will consume one capsule per day for 2 months treatment period
Preforpro
Preforpro will be investigated to improve vaginal health in women with BV.
Placebo
placebo will come in a capsule, which has to be consumed one capsule per day for 2 months treatment period
Placebo
Placebo capsules manufactured to look like Preforpro capsules
Interventions
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Preforpro
Preforpro will be investigated to improve vaginal health in women with BV.
Placebo
Placebo capsules manufactured to look like Preforpro capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18-45 years old premenopausal (period within 6 months)
* Nugent score of 4-6 (intermediate) or 7-10 (BV)
* Have an ability to collect a clean urine sample
* Prescription and over the counter medication unchanged for \> 30 days prior to the study. -Participants who are taking medications as needed (PRN) may be included if they began PRN usage \>30 days prior to baseline
* Sexually active status of the participants can be either active or inactive
* Participants must agree to use a medically approved method of birth control (e.g. hormonal contraceptives, intrauterine devices, vasectomy/tubal ligation, barrier methods and double-barrier method) and must have negative pregnancy test results at screening and baseline
Exclusion Criteria
* History of urinary fistula, bladder or kidney stones, interstitial cystitis, or cystoscopic abnormalities that could be malignant
* Neurogenic bladder
* A history of currently undergoing immunosuppressive drug therapy, chemotherapy, or radiation therapy
* Antibiotic and/or anti-fungal medication used within the last four weeks
* Oral probiotic supplement use within 2 weeks prior the study excluding yogurt
* Drug abuse
* Uncontrolled psychological disorders
18 Years
45 Years
FEMALE
Yes
Sponsors
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Deerland Enzymes
INDUSTRY
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
St. Joseph's Health Care London
OTHER
Jeremy Burton
OTHER
Responsible Party
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Jeremy Burton
Principal Investigator, PhD
Principal Investigators
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Jermy Burton
Role: PRINCIPAL_INVESTIGATOR
Lawson HRI
Central Contacts
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Other Identifiers
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BVPFB2021
Identifier Type: -
Identifier Source: org_study_id
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