Effect of PreforPro® on Urinary and Vaginal Health

Last updated: January 5, 2024
Sponsor: Jeremy Burton
Overall Status: Active - Not Recruiting

Phase

3

Condition

Vaginal Infection

Bacterial Infections

Vaginal Atrophy

Treatment

Preforpro

Placebo

Clinical Study ID

NCT05590195
BVPFB2021
  • Ages 18-45
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 thestudy. -Participants who are taking medications as needed (PRN) may be included ifthey 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, barriermethods and double-barrier method) and must have negative pregnancy test results atscreening and baseline

Exclusion

Exclusion Criteria:

  • Faecal incontinence
  • History of urinary fistula, bladder or kidney stones, interstitial cystitis, orcystoscopic abnormalities that could be malignant
  • Neurogenic bladder
  • A history of currently undergoing immunosuppressive drug therapy, chemotherapy, orradiation 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

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Preforpro
Phase: 3
Study Start date:
May 01, 2024
Estimated Completion Date:
June 01, 2025

Study 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.