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

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 3 and 12-weeks all women will be invited back for a 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.

Conditions

• Bacterial Vaginosis
• Candida Vaginal

Interventions

OTHER

Vaginal lactoferrin

Lactoferrin vaginal pessaries to insert nightly for 21 nights

DRUG

Usual care

Women with bacterial vaginosis will be given oral metronidazole and women with vaginal candida will be given oral fluconazole

Sponsors & Collaborators

• King's College London

  collaborator OTHER

• Statens Serum Institut

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  lead OTHER

Principal Investigators

• Pippa Oakeshott, MD · St George's, University of London

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-31

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• United Kingdom

Study Locations