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NCT05590195

Effect of PreforPro® on Urinary and Vaginal Health

Status unknown Phase 3 Last updated 9 January 2024
What this trial tests

Phase 3 trial testing Preforpro in Bacterial Vaginosis in 50 participants. Status unknown.

Timeline
1 May 2024
Primary endpoint
1 March 2025
1 June 2025

Quick facts

Lead sponsorJeremy Burton
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment50
Start date1 May 2024
Primary completion1 March 2025
Estimated completion1 June 2025

Drugs / interventions tested

Conditions studied

Sponsor

Jeremy Burton — full company profile →

Who can join

Adults 18 to 45, female only, with Bacterial Vaginosis or Bacterial Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Regulations of phage therapy across the world.
    Yang Q, Le S, Zhu T, Wu N. · · 2023 · cited 86× · PMID 37869667 · DOI 10.3389/fmicb.2023.1250848
  2. Emerging antimicrobial therapies for Gram-negative infections in human clinical use.
    Hickson SM, Ledger EL, Wells TJ. · · 2025 · cited 11× · PMID 40016340 · DOI 10.1038/s44259-025-00087-2
  3. Antimicrobial Resistance: The Answers.
    Millar BC, Cates MJ, Torrisi MS, Round AJ, et al · · 2026 · PMID 41727556 · DOI 10.3389/bjbs.2026.15559
  4. A Century of Bacteriophages: Insights, Applications, and Current Utilization.
    Dkhili S, Ribeiro M, Slama KB. · · 2025 · PMID 41301576 · DOI 10.3390/antibiotics14111080

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Other recruiting trials for Bacterial Vaginosis

Currently open trials in the same condition.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing