Lactoferrin as an alternative to antibiotics for BV or yeast infections in women
Official title: Is the Naturally Occurring Prebiotic Lactoferrin an Acceptable Alternative to Antibiotic/Antifungal Tablets for Women With Bacterial Vaginosis or Thrush?
Run by Guy's and St Thomas' NHS Foundation Trust · NCT05434104 · Data updated 2026-11-12
This study tests whether vaginal lactoferrin pessaries can replace oral antibiotics/antifungals for BV or candida infections in women.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Years to 50 Years |
| Sex | Women only |
| Enrollment | 114 (estimated) |
| Sponsor | Guy's and St Thomas' NHS Foundation Trust Academic / other |
| Locations | 2 sites (London and 1 other locations) |
| Status | Recruiting |
| Started | April 16, 2026 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | May 29, 2026 |
| Trial ID | NCT05434104 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 16-49 with clinically diagnosed BV or candidiasis who consent to randomization and sample submission.
✕Probably not a fit
Women who are pregnant, breastfeeding, or have infections with chlamydia, gonorrhoea, or trichomonas may not benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a feasibility, open-label randomized study looking at vaginal lactoferrin vs. standard oral antibiotics/antifungals in women aged 16-49 with BV or candida infections. It uses 12 weeks of follow-up with qualitative, economic, and microbiological evaluations to see if a future definitive trial is doable. The goal is to determine if vaginal lactoferrin can lead to symptom resolution, prevent recurrence, and promote a Lactobacillus-dominated vaginal microbiome. The study is conducted at a sexual health clinic and a general practice in London, led by Guy’s and St Thomas’ NHS Foundation Trust with collaboration from King’s College London and Statens Serum Institut.
Why it matters
Potential benefit: If successful, this approach could offer a non-antibiotic option that preserves healthy vaginal bacteria and reduces antimicrobial resistance risk.
How similar studies have gone: Prior research suggests lactoferrin may help with BV and candidiasis, but robust evidence from randomized trials is still needed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 16-49 years * Having periods (apart from women with a Mirena IUCD or polycystic ovary syndrome) * Ability to consent * Clinical diagnosis of BV or thrush confirmed on Gram stain * Willing to be randomised to vaginal lactoferrin pessaries or oral antibiotics/antifungals * Agrees to provide vaginal samples at home and post/deliver them back to the research team. * Agrees to avoid douching during the study (as this can flush out lactobacilli needed for a healthy microbiome). Exclusion Criteria: * Pregnant or breast feeding * Currently has chlamydia, gonorrhoea or trichomonas (as treatment for these would affect the results). * Known allergy to metronidazole or azoles * Post-menopausal (because of diagnostic confusion between atrophic vaginitis and bacterial vaginosis)
Where it's running
-
Guy's and St Thomas' Sexual Health Clinic
London, United Kingdom Recruiting -
St Thomas' NHS Trust
London, United Kingdom Not yet recruiting
Study contacts
- Principal investigator: Pippa Oakeshott, MD — St George's, University of London
- Study coordinator: Pippa Oakeshott, MD
- Email: oakeshot@sgul.ac.uk
- Phone: 020 8725 0153
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.