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Effect of PreforPro® on Urinary and Vaginal Health

Primary Purpose

Bacterial Vaginosis, Bacterial Infections, Bacterial Vaginosis | Vaginal | Microbiology

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Preforpro
Placebo
Sponsored by
Jeremy Burton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Vaginosis

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female
  • 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:

  • Faecal incontinence
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    PreforPro

    Placebo

    Arm Description

    Preforpro Dosage form - capsule Dosage - participants will consume one capsule per day for 2 months treatment period

    placebo will come in a capsule, which has to be consumed one capsule per day for 2 months treatment period

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    Determine change in vaginal cell exfoliation.
    Vaginal swab is collected to determine the amount of epithelial cell exfoliation.
    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.
    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.

    Full Information

    First Posted
    October 6, 2022
    Last Updated
    February 17, 2023
    Sponsor
    Jeremy Burton
    Collaborators
    Deerland Enzymes, Lawson Health Research Institute, St. Joseph's Health Care London
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05590195
    Brief Title
    Effect of PreforPro® on Urinary and Vaginal Health
    Official Title
    Effect of PreforPro® (Prebiotic and Bacteriophage) on Urinary and Vaginal Health
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2025 (Anticipated)
    Study Completion Date
    June 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jeremy Burton
    Collaborators
    Deerland Enzymes, Lawson Health Research Institute, St. Joseph's Health Care London

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bacterial Vaginosis, Bacterial Infections, Bacterial Vaginosis | Vaginal | Microbiology, Vaginal Infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Double-blinded, randomized, placebo controlled study
    Masking
    ParticipantInvestigator
    Masking Description
    Neither participants nor study team will know which product the participants have been assigned. Unblinding can be requested from the pharmacy if necessary.
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PreforPro
    Arm Type
    Experimental
    Arm Description
    Preforpro Dosage form - capsule Dosage - participants will consume one capsule per day for 2 months treatment period
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    placebo will come in a capsule, which has to be consumed one capsule per day for 2 months treatment period
    Intervention Type
    Drug
    Intervention Name(s)
    Preforpro
    Intervention Description
    Preforpro will be investigated to improve vaginal health in women with BV.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Placebo for PreforPro
    Intervention Description
    Placebo capsules manufactured to look like Preforpro capsules
    Primary Outcome Measure Information:
    Title
    To change Nugent score in women with intermediate grade or BV
    Description
    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.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Determine whether the bacteriophage can translocate from the gastrointestinal system to genitourinary system.
    Description
    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.
    Time Frame
    3 months
    Title
    Determine if the microbiota in the gut and urinary system change
    Description
    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.
    Time Frame
    3 months
    Title
    Determine change in vaginal cell exfoliation.
    Description
    Vaginal swab is collected to determine the amount of epithelial cell exfoliation.
    Time Frame
    3 months
    Title
    Determine whether probiotics can translocate from the gastrointestinal system to genitourinary system.
    Description
    MSU microbiota analysis will be performed on the urine and faecal sample to determine the species present in both samples.
    Time Frame
    3 months
    Title
    Determine change in urogenital ATP levels.
    Description
    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.
    Time Frame
    3 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    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.
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Female 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: Faecal incontinence 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jermy Burton, PhD
    Phone
    5196466100
    Ext
    61365
    Email
    jeremy.burton@LawsonResearch.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alexandria R Agudelo, MLA
    Phone
    5196466100
    Ext
    42696
    Email
    alexandria.roaagudelo@sjhc.london.on.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jermy Burton
    Organizational Affiliation
    Lawson HRI
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of PreforPro® on Urinary and Vaginal Health

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