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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St George's, University of London
• Collaborators: King's College London; Statens Serum Institut
• Treatments: Fluconazole; Lactoferrin; Metronidazole

Criteria

Inclusion Criteria:

• Aged 16-50 years

• Having regular periods (apart from women with a Mirena IUCD)

• 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).

• Already using oral or topical antibiotics/antifungals, or used these within the last 2-weeks.

• Known allergy to metronidazole or azoles

• Post-menopausal (because of diagnostic confusion between atrophic vaginitis and bacterial vaginosis)