Clinical trial NCT05590195: Effect of PreforPro® on Urinary and Vaginal Health
Official title: Effect of PreforPro® (Prebiotic and Bacteriophage) on Urinary and Vaginal Health
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Bacterial Vaginosis
Bacterial Infections
Bacterial Vaginosis &#X7C; Vaginal &#X7C; Microbiology
Vaginal Infection
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Deerland Enzymes
name: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: St. Joseph's Health Care London
First posted: 2022-10-21
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded, randomized, placebo controlled study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To change Nugent score in women with intermediate grade or BV
timeFrame: 3 months
Secondary outcomes:
measure: Determine whether the bacteriophage can translocate from the gastrointestinal system to genitourinary system.
timeFrame: 3 months
measure: Determine if the microbiota in the gut and urinary system change
timeFrame: 3 months
measure: Determine change in vaginal cell exfoliation.
timeFrame: 3 months
measure: Determine whether probiotics can translocate from the gastrointestinal system to genitourinary system.
timeFrame: 3 months
measure: Determine change in urogenital ATP levels.
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Lawson HRI
name: Jermy Burton
role: PRINCIPAL_INVESTIGATOR
References: