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New treatment option for Bacterial Vaginosis
Official title The LISA (Lactoferrin InStead of Antibiotics/Antifungals) Feasibility Study
ClinicalTrials.gov ID: NCT05434104
What this study is testing
- What it's testing
- Three-quarters of women have bacterial vaginosis (BV) or vaginal thrush/candida yeast infection at least once during their lifetime. Symptoms can include abnormal vaginal discharge, soreness, itching and an unpleasant smell.
- Time commitment: about 12 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 50, women only
You may be able to join if
- 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 assigned by chance to vaginal lactoferrin pessaries or oral antibiotics/antifungals
You likely can't join if
- 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)
See the full eligibility 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 assigned by chance 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).
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 16 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.