The LISA (Lactoferrin InStead of Antibiotics/Antifungals) Feasibility Study
Status:
Not yet recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
Summary
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 confirmed.
Aim To see if it is feasible to conduct a future trial to prove whether lactoferrin vaginal
pessaries are an acceptable, effective and cost-effective alternative to antibiotic tablets
for women with BV or thrush.
Methods The investigators will recruit a total of 57 women with BV and 57 with thrush from
two sexual health clinics and a general practice. Women will be asked to provide self-taken
vaginal samples with a cotton bud, and to complete a confidential sexual-health
questionnaire. Then the women will be divided into two groups. One group will be given
lactoferrin vaginal pessaries to use every night for 3-weeks. The other group will be given
antibiotic/antifungal tablets. All women will be asked to provide repeat vaginal samples at
home and text us about any symptoms to see if the treatment works, if the infection comes
back and if they would like antibiotics. After 12-weeks all women will be invited back for a
final check-up.
Outcome measures:
- Acceptability and use of vaginal lactoferrin - from questionnaires, and interviews with
15-20 women
- Recruitment and follow-up rates
- Cost of lactoferrin treatment
- The percentage of women who report their symptoms have resolved after a week
- How quickly infections clear or recur - from analysis of samples
Patient benefit:
If this study leads to a trial showing vaginal lactoferrin is an acceptable and effective
alternative to antibiotics, this could help relieve symptoms, prevent antimicrobial
resistance and save NHS costs.