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| Name | Class |
|---|---|
| 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 |
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This study will investigate the effects of PreforPro® (prebiotic and bacteriophages (LH01-Myoviridae, LL5-Siphoviridae, T4D-Myoviridae, and LL12-Myoviridae, greater > 6.7 X 107 PFU/gram) on bacterial vaginosis.
This is a double-blinded, placebo controlled study. Each study participant will be in the study for 90 days. During the first 28 days the participants will not take study product, and will collect samples for the study in order to act as their own controls. On day 29, participants will be randomized to intervention with either PreforPro® or placebo, which they will take once daily for the remaining 62 days. There will be a total of 5 study visits during which samples will be collected, a Quality of Life questionnaire will be completed at baseline and end of study visit.
Samples for the study are: vaginal swab, faecal sample, urine sample.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PreforPro | Experimental | Preforpro Dosage form - capsule Dosage - participants will consume one capsule per day for 2 months treatment period |
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| Placebo | Placebo Comparator | placebo will come in a capsule, which has to be consumed one capsule per day for 2 months treatment period |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preforpro | Drug | Preforpro will be investigated to improve vaginal health in women with BV. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To change Nugent score in women with intermediate grade or BV | Vaginal swab is collected to determine the Nugent score, which is a The Nugent Score is a gram stain scoring system for vaginal swabs to diagnose bacterial vaginosis. Nugent scores between 7-10 is the standard diagnosis of BV and indicative of the absence of lactobacilli and a relative predominance of G. vaginalis and Mobiluncus spp. A Nugent score of 4-6 is indicative of intermediate BV. A Nugent score ≤ 3 means there is no BV. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Determine whether the bacteriophage can translocate from the gastrointestinal system to genitourinary system. | Urine will be analyzed to determine the amount of antibiotic resistant genes by reverse transcriptase-quantitative polymerase chain reaction (qPCR). The Faecal sample will also be analyzed to determine bacteriophage counts by qPCR. These two tests will tell us if the bacteriophage was able to translocate between the two systems. |
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Inclusion Criteria:
Exclusion Criteria:
This study is conducted in premenopausal females to improve the vaginal health in women with BV. Hence the participant eligibility is based on the gender.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jermy Burton, PhD | Contact | 5196466100 | 61365 | jeremy.burton@LawsonResearch.com |
| Alexandria R Agudelo, MLA | Contact | 5196466100 | 42696 | alexandria.roaagudelo@sjhc.london.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jermy Burton | Lawson HRI | Principal Investigator |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| D001424 | Bacterial Infections |
| D014627 | Vaginitis |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
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Double-blinded, randomized, placebo controlled study
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Neither participants nor study team will know which product the participants have been assigned. Unblinding can be requested from the pharmacy if necessary.
| Placebo |
| Other |
Placebo capsules manufactured to look like Preforpro capsules |
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| 3 months |
| Determine if the microbiota in the gut and urinary system change | To determine this outcome the study team will test quantify and capture E. coli isolates from a urine sample. MSU microbiota analysis will be performed on the sample, and bacteriophage counts will be determined by qPCR. | 3 months |
| Determine change in vaginal cell exfoliation. | Vaginal swab is collected to determine the amount of epithelial cell exfoliation. | 3 months |
| Determine whether probiotics can translocate from the gastrointestinal system to genitourinary system. | MSU microbiota analysis will be performed on the urine and faecal sample to determine the species present in both samples. | 3 months |
| Determine change in urogenital ATP levels. | Urine sample will be collected to quantify urogenital ATP level. A luminescent assay kit (BacTiter-Glo microbial cell viability assay; Promega, WI) will be used to quantify the amount of ATP. The Synergy H4 hybrid multimode microplate reader will be used to quantify the amount of ATP. | 3 months |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |