Trials / Unknown
UnknownNCT05590195
Effect of PreforPro® on Urinary and Vaginal Health
Effect of PreforPro® (Prebiotic and Bacteriophage) on Urinary and Vaginal Health
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Jeremy Burton · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Bacterial Vaginosis
- Bacterial Infections
- Bacterial Vaginosis | Vaginal | Microbiology
- Vaginal Infection
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Preforpro | Preforpro will be investigated to improve vaginal health in women with BV. |
| OTHER | Placebo | Placebo capsules manufactured to look like Preforpro capsules |
Timeline
- Start date
- 2024-05-01
- Primary completion
- 2025-03-01
- Completion
- 2025-06-01
- First posted
- 2022-10-21
- Last updated
- 2024-01-09
Source: ClinicalTrials.gov record NCT05590195. Inclusion in this directory is not an endorsement.