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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05590195
Other study ID # BVPFB2021
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date May 1, 2024
Est. completion date June 1, 2025

Study information

Verified date January 2024
Source Lawson Health Research Institute
Contact Jermy Burton, PhD
Phone 5196466100
Email jeremy.burton@LawsonResearch.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date June 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Intervention

Drug:
Preforpro
Preforpro will be investigated to improve vaginal health in women with BV.
Other:
Placebo
Placebo capsules manufactured to look like Preforpro capsules

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Jeremy Burton Deerland Enzymes, Lawson Health Research Institute, St. Joseph's Health Care London

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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. 3 months
Secondary 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
Secondary Determine change in vaginal cell exfoliation. Vaginal swab is collected to determine the amount of epithelial cell exfoliation. 3 months
Secondary 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
Secondary 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
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