Effect of PreforPro® on Urinary and Vaginal Health

NCT05590195 | Unknown Phase 3

• 1 other identifier: BVPFB2021
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bacterial Vaginosis; Bacterial Infections; Bacterial Vaginosis | Vaginal | Microbiology; Vaginal Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Determine whether the bacteriophage can translocate from the gastrointestinal system to genitourinary system.

  3 months

• Determine if the microbiota in the gut and urinary system change

  3 months

• Determine change in vaginal cell exfoliation.

  3 months

• Determine whether probiotics can translocate from the gastrointestinal system to genitourinary system.

  3 months

• Determine change in urogenital ATP levels.

  3 months

Study Arms (2)

PreforPro

EXPERIMENTAL

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

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

Other: Placebo

Interventions

Preforpro DRUG

Preforpro will be investigated to improve vaginal health in women with BV.

PreforPro

Placebo OTHER

Placebo capsules manufactured to look like Preforpro capsules

Also known as: Placebo for PreforPro

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jeremy Burton: lead
• Deerland Enzymes: collaborator
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator
• St. Joseph's Health Care London: collaborator

MeSH Terms

Conditions

Vaginosis, Bacterial; Bacterial Infections; Vaginitis

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Jermy Burton

  Lawson HRI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jermy Burton, PhD

CONTACT

5196466100; jeremy.burton@LawsonResearch.com

Alexandria R Agudelo, MLA

CONTACT

5196466100; alexandria.roaagudelo@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither participants nor study team will know which product the participants have been assigned. Unblinding can be requested from the pharmacy if necessary.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, PhD

Model Details: Double-blinded, randomized, placebo controlled study

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 21, 2022
• Study Start: May 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 9, 2024

Record last verified: 2024-01