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The LISA (Lactoferrin InStead of Antibiotics/Antifungals) Feasibility Study

RecruitingNAAges 16 Years - 50 YearsFemaleGuy's and St Thomas' NHS Foundation Trust
NCT05434104 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. BV during pregnancy can make the baby come too early. In the UK over a million women suffer recurrent vaginal infections. These can affect their sexual relationships and quality of life, and may need repeated courses of treatment. But some women prefer not to keep taking antibiotics which can have side effects and encourage the growth of resistant superbugs. Lactoferrin is a prebiotic protein derived from cow's milk. Women also have naturally occurring lactoferrin in their vagina where it helps to prevent infections and encourage the growth of healthy bacteria. Recent research suggests lactoferrin may be an effective treatment for BV and thrush, but this needs to be

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📋 Eligibility rules (as published)
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)
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What it tests

  • Vaginal lactoferrin
  • Usual care
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Where

2 sites
St Thomas' NHS Trust
London, United Kingdom
Guy's and St Thomas' Sexual Health Clinic
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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