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The Population Health Research Institute at St George’s, University of London is conducting a feasibility study of using Lactoferrin instead of antibiotics/antifungals for women with thrush or bacterial vaginosis. This is called the LISA study. The study is funded by the National Institute for Health and Care Research.

IRAS ID: 30789.

Aim of the study

We are conducting this study to find out if we can do a future study to see if naturally occurring Lactoferrin (made from cows’ milk) might be an alternative to antibiotic/antifungal tablets for women with bacterial vaginosis or thrush.

Who can take part?

Women aged 16 to 49 years-old who have vaginal symptoms due to bacterial vaginosis or thrush. They must be patients at the Burrell Street Sexual Health Clinic or the Curran General Practice

What is involved in this study?

Women involved in this study will be asked to complete short, confidential questionnaires and provide self-taken vaginal samples with a cotton bud. You may also be asked if you agree to a brief telephone interview about the study.

Some women will be given lactoferrin vaginal pessaries and some women will be given antibiotic or antifungal tablets.

What's in it for me?

You will get check-ups from a doctor and free treatment. When you come back to the clinic/practice for a final check after three months you will be given £30 for your help. Women who take part in telephone interview will get an extra £10.

To find out more about this study please click the sections below.

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Background and introduction
Study title: Is the naturally occurring prebiotic Lactoferrin an acceptable alternative to antibiotic/antifungal tablets for women with bacterial vaginosis or thrush? The LISA (Lactoferrin InStead of Antibiotics/antifungals) randomised feasibility study.

Bacterial vaginosis (BV) and vaginal thrush/candida are common infections affecting over 200,000 women each year in England, with an estimated annual cost to the NHS of more than £60 million.

Symptoms of BV and candida may include abnormal vaginal discharge and soreness, itching or burning in and around the vagina. BV can also cause an unpleasant fishy smell. Women with BV are at increased risk of HIV infection, pelvic inflammatory disease, late miscarriage and preterm birth. Similarly, vaginal thrush may be associated with HIV infection and preterm birth which is the main cause of neonatal death and disability worldwide.

In the UK an estimated 1.2 million women have recurrent vaginal infections. Although some women report little impact on their lives, in others recurrent infections can be socially and sexually disabling, affecting their relationships, self-esteem and quality of life.

Both BV and vaginal thrush are usually treated with oral antibiotics/antifungals. Unfortunately, about a third of women suffer recurrent infections. These women may be given multiple courses of antibiotics which may cause side effects and increase the risk of antimicrobial resistance.

We want to see if naturally occurring Lactoferrin (made from cows’ milk) might be an alternative to antibiotic/antifungal tablets for women with bacterial vaginosis or thrush.

What is lactoferrin?

Vaginal lactoferrin is made from cows’ milk. It encourages the growth of healthy lactobacilli in the vagina and may prevent bacterial vaginosis and thrush.

Lactoferrin has been used in research studies by nearly 200 women (including during pregnancy) with no recorded adverse events.

In 2019-2020, women bought over 60,000 boxes of vaginal lactoferrin (Difesan) and no serious adverse events were reported. 

About the LISA trial

LISA is an open label randomised feasibility study to investigate if a future definitive trial can be conducted which proves that vaginal lactoferrin is an acceptable, safe and effective alternative to antibiotics/antifungals for women with Bacterial vaginosis or thrush. 

Sponsors and funding

The study is funded by the National Institute for Health and Care Research under its Research for Patient Benefit programme (RfPB) and is sponsored by St George's, University of London.

Trial design

LISA is an open label randomised feasibility trial over 12 weeks with qualitative, microbiological, and economic evaluations.

Trial setting

For this feasibility study we will only recruit women attending the Burrell Street Sexual Health Clinic or the Curran General Practicein London. 

Target population

A total of 114 women will be recruited for this study.

Who can take part

Women who:

  • are aged 16 to 49 years who have vaginal symptoms due to bacterial vaginosis or thrush
  • have periods (apart from women with a Mirena IUCD or polycystic ovary syndrome)
  • have a clinical diagnosis of bacterial vaginosis or thrush confirmed on Gram stain.
Trial flow chart

Flow chart to show the stages of the LISA trial.

View the trial flow chart document here (Word).

Trial treatments

Intervention arm: Vaginal lactoferrin

38 women with bacterial vaginosis and 38 women with Candida will be given bovine lactoferrin 300mg vaginal pessaries (Difesan, Uriach, Italy) to insert every evening for the first 21 days of the study.

Control arm: Usual oral antibiotic/antifungal treatment

19 women with bacterial vaginosis will be given metronidazole 400mg twice daily for 5 days. 19 women with candida will be given a fluconazole 150mg capsule to take the same day.

  • Acceptability of vaginal lactoferrin from questionnaires and interviews
  • Adherence to treatment (from participants’ weekly count of remaining pessaries/tablets)
  • Recruitment rate and willingness of women to be randomised
  • Follow-up rate
  • Acceptability of study procedures such as providing vaginal samples and responding to texts about symptoms
  • Adverse events
  • Estimate of the cost of lactoferrin and the feasibility of obtaining data on healthcare use.
  • Percent of participants completing symptom questionnaires
  • Percent of participants providing samples suitable for microbiological analyses (e.g. To assess for a healthy lactobacilli-dominated vaginal microbiome) to inform the design of a future definitive trial.
What happens to women who take part in the study?

Week 1: Provide self-taken vaginal samples at home every evening for 7 days. Receive text questionnaires on day 4 and 7.

Week 2, 3 and 4: Vaginal samples taken at home in the evening twice a week. Receive text twice a week to ask about symptoms.

Week 5 to 11: No contact.

Week 12: Invited back to clinic or general practice for a final check up.

Trajectory to patient benefit

If this study leads to a future trial which proves that vaginal lactoferrin is an acceptable, safe, and effective alternative to antibiotics, using lactoferrin could:

  • help relieve symptoms
  • reduce recurrence rates
  • prevent antimicrobial resistance
  • save NHS costs.

Future research might show if lactoferrin could also reduce infection-related preterm birth.


Participants will be given a £30 honorarium when they attend for the final 12-week check. Those who take part in interviews will receive an additional £10.

Patient information/study documents

Meet the team

Names, job titles and images for each member of the LISA study team.
Photo of Pippa Oakeshott.
Photo of Fiona Reid. Photograph of Phillip Hay

Pippa Oakeshott
Chief Investigator & General Practitioner

Fiona Reid
Senior Lecturer in Statistics
Phillip Hay
Sexual Health Consultant
Photo of Salma Ayis. Photo of Katy Turner. Jorgen Skov Jensen
Salma Ayis
Senior Lecturer in Statistics
Katy Turner
Health Economist
Jorgen Skov Jensen
Consultant Medical Microbiologist
Iva Zlatareva Photo of Nilofer Dayal. Photograph of Sima Hay
Iva Zlatareva
Nilofer Dayal
Trial Manager
Sima Hay
Senior Lecturer
Department of Midwifery

Contact information

If you have any questions please feel free to contact one of our research team members:

Information from the British Association for Sexual Health and HIV (BASHH):

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