Developing a live biotherapeutic to improve vaginal health
THE SCOPE OF THIS TASK ORDER IS (1). PRODUCTION OF A DRUG SUBSTANCE, (2) CONVERSION OF DRUG SUBSTANCE TO DRUG PRODUCT, (3) FILLING DRUG PRODUCT INTO APPLICATORS TO BE USED IN THE CLINICAL TRIALS, AND
This study is testing a new treatment made from good bacteria to help women with bacterial vaginosis and improve their vaginal health, which may also lower the risk of cervical issues.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Midwest Research Institute NIH-funded |
| Lab location | 1 site (Kansas City, United States) |
| Project ID | NIH-11219071 on NIH RePORTER |
What this research studies
This research focuses on producing a live biotherapeutic drug, Lactobacillus crispatus, aimed at correcting the vaginal microflora in women suffering from bacterial vaginosis and vaginal dysbiosis. By restoring a healthy balance of bacteria, the treatment seeks to reduce the risk of cervical dysplasia and cervical cancer. Patients will receive this biotherapeutic product during clinical trials, which will assess its effectiveness and safety. The approach involves producing the drug substance, converting it into a usable product, and filling it into applicators for administration.
Who could benefit from this research
Good fit: Ideal candidates for this research are women diagnosed with bacterial vaginosis or vaginal dysbiosis.
Not a fit: Patients who do not have bacterial vaginosis or related vaginal health issues may not benefit from this research.
Why it matters
Potential benefit: If successful, this research could significantly lower the risk of cervical dysplasia and cancer in women with bacterial vaginosis.
How similar studies have performed: Previous research has shown promise in using live biotherapeutics to restore vaginal health, indicating potential success for this approach.
Where this research is happening
Kansas City, United States
- Midwest Research Institute — Kansas City, United States (Active)
Researchers
- Principal investigator: White, Jon — Midwest Research Institute
- Study coordinator: White, Jon
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.