Bacterial VaginosisPhase 3NCT05590195
Effect of PreforPro® on Urinary and Vaginal Health
A Phase 3 study testing Preforpro in people with Bacterial Vaginosis and Bacterial Infections, run by Jeremy Burton.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Vaginosis, Bacterial Infections, Bacterial Vaginosis | Vaginal | Microbiology
- What is being tested?
- Preforpro
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of PreforPro® (Prebiotic and Bacteriophage) on Urinary and Vaginal Health
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.
Read the 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.
- Conditions
- Bacterial Vaginosis, Bacterial Infections, Bacterial Vaginosis | Vaginal | Microbiology, Vaginal Infection
- Being tested
- Preforpro, Placebo
- Medical subject headings
- Vaginosis, Bacterial, Bacterial Infections, Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PreforproDrug
Preforpro will be investigated to improve vaginal health in women with BV.
PlaceboOther
Also called Placebo for PreforPro
Placebo capsules manufactured to look like Preforpro capsules
| Study group | Role | What they receive |
|---|---|---|
| PreforPro | Experimental | Preforpro Dosage form - capsule Dosage - participants will consume one capsule per day for 2 months treatment period Receives: Drug: Preforpro |
| Placebo | Placebo comparator | placebo will come in a capsule, which has to be consumed one capsule per day for 2 months treatment period Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 3 months
Determine change in vaginal cell exfoliation.
Vaginal swab is collected to determine the amount of epithelial cell exfoliation.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 May 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded, randomized, placebo controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeremy Burton
- Sponsor type
- University, hospital or other
- Collaborators
- Deerland Enzymes, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, St. Joseph's Health Care London
- Responsible party
- Sponsor-investigator, Jeremy Burton, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Jermy Burton, Principal investigator, Lawson HRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590195
- Sponsor's protocol ID
- BVPFB2021
- Status last verified
- Jan 2024
- First submitted
- 6 Oct 2022
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PreforPro® (Prebiotic and Bacteriophage) on Urinary and Vaginal Health
- ClinicalTrials.gov ID
- NCT05590195
- Acronym / sponsor ID
- BVPFB2021
- Conditions
- Bacterial Vaginosis, Bacterial Infections, Bacterial Vaginosis | Vaginal | Microbiology, Vaginal Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jeremy BurtonUniversity, hospital or other
- Collaborators
- Deerland Enzymes, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's, St. Joseph's Health Care London
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blinded, randomized, placebo controlled study
| Arm | Type | Receives |
|---|---|---|
| PreforPro | Experimental | Drug: PreforproPreforpro Dosage form - capsule Dosage - participants will consume one capsule per day for 2 months treatment period |
| Placebo | Placebo comparator | Other: Placeboplacebo will come in a capsule, which has to be consumed one capsule per day for 2 months treatment period |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PreforproPreforpro will be investigated to improve vaginal health in women with BV. | Drug | PreforPro |
| PlaceboAlso: Placebo for PreforProPlacebo capsules manufactured to look like Preforpro capsules | Other | Placebo |
Primary outcome
To change Nugent score in women with intermediate grade or BV
Time frame: 3 months
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.
5 secondary outcomes
Determine whether the bacteriophage can translocate from the gastrointestinal system to genitourinary system.
Time frame: 3 months
Determine if the microbiota in the gut and urinary system change
Time frame: 3 months
Determine change in vaginal cell exfoliation.
Time frame: 3 months
Determine whether probiotics can translocate from the gastrointestinal system to genitourinary system.
Time frame: 3 months
Determine change in urogenital ATP levels.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jermy Burton principal investigator
Lawson HRI
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Preforpro in people with Bacterial Vaginosis and Bacterial Infections, run by Jeremy Burton.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jermy Burton, PhD (5196466100 ext. 61365, jeremy.burton@LawsonResearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To change Nugent score in women with intermediate grade or BV (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.