RecruitingNAINTERVENTIONAL

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

This study, called LISA, explores a new approach to treating common vaginal infections like bacterial vaginosis (BV) and thrush. Many women suffer from these infections repeatedly, which can impact their daily lives and lead them to take antibiotics often. This study is testing if lactoferrin, a natural protein found in milk, can be an effective way to treat these infections instead of traditional antibiotics. Researchers want to find out if using lactoferrin vaginal pessaries is a practical, acceptable, and effective treatment option for women. If successful, this could reduce the need for antibiotics, which can have side effects and contribute to antibiotic resistance.

At a glance

Status

Recruiting

Phase

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrolment target

114

Start

16 Apr 2026

Estimated completion

01 Dec 2027

Bacterial Vaginosis Candida Vaginal

What is this study about?

Many women experience common vaginal infections such as thrush (Candida) and bacterial vaginosis (BV) at some point in their lives. These can cause uncomfortable symptoms like unusual discharge, itching, soreness, and an unpleasant smell. For some women, these infections keep coming back, which can be upsetting and affect their relationships and overall quality of life. While antibiotics are typically used to treat these, they can sometimes cause side effects or lead to bacteria becoming resistant to the medication over time, making future infections harder to treat.

This study, called LISA (Lactoferrin InStead of Antibiotics/Antifungals), is looking into a different option: lactoferrin. Lactoferrin is a protein found naturally in milk, including cow's milk. It's also present in a woman's vagina, where it helps to keep harmful bacteria away and encourages the growth of good, healthy bacteria. Previous research suggests that lactoferrin might be a good way to treat BV and thrush, but more evidence is needed to confirm this.

The main goal of this study is to see if it's possible to run a larger trial in the future to prove that lactoferrin vaginal pessaries are a good choice – whether they are effective, women find them easy to use, and they could be an affordable alternative to antibiotic tablets for BV and thrush. If this study shows promise, it could open the door to a new, gentler treatment that helps women manage these common infections more effectively and with fewer side effects.

Key takeaways

New study exploring lactoferrin for thrush and BV.
Aims to find an alternative to antibiotics.
May offer fewer side effects and reduce antibiotic resistance.
Compares lactoferrin pessaries with standard oral treatment.
Involves home sampling and text message updates.
Study lasts 12 weeks with two clinic check-ups.

Who may be eligible?

This study is looking for women aged between 16 and 49 years old who are still having their periods. This includes women who use a Mirena coil or have polycystic ovary syndrome.

You would need to have been diagnosed with either bacterial vaginosis (BV) or thrush, confirmed by specific lab tests. You also need to be willing to be randomly assigned to use either the lactoferrin pessaries or standard antibiotic/antifungal tablets.

Unfortunately, you cannot take part if you are pregnant or breastfeeding, or if you have certain other infections like chlamydia or gonorrhoea, as these would affect the study results. If you have a known allergy to common antibiotics used for these conditions (like metronidazole) or if you have already gone through menopause, you would also not be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 16 and 49 years old?
Are you currently having periods?
Have you been diagnosed with BV or thrush?
Are you not pregnant or breastfeeding?
Are you willing to use either pessaries or tablets?
Do you not have an allergy to antibiotics like metronidazole?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first be asked to fill out some questionnaires about your sexual health and provide a vaginal sample using a cotton bud, which you can do yourself. After this, you'll be randomly assigned to one of two groups. One group will use lactoferrin vaginal pessaries every night for three weeks. The other group will take standard antibiotic or antifungal tablets as prescribed by your doctor.

Throughout the study, you'll be asked to provide more vaginal samples from home and send text messages to the research team about your symptoms. This helps us understand if the treatment is working, if the infection returns, and whether you'd still want antibiotics. You will have a check-up at the clinic after three weeks and again after 12 weeks. The total time you'd be involved in the study would be 12 weeks.

Potential risks and benefits

Taking part could help us understand if lactoferrin is a good alternative treatment for vaginal infections, potentially leading to fewer side effects from antibiotics and helping to reduce antibiotic resistance. You might also receive a new treatment for your infection. However, there's no guarantee the treatment will work for you, and like all medications, lactoferrin could have potential side effects, although these are expected to be mild. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

St Thomas' NHS Trust
Verified postcode
London, United Kingdom· Not yet recruiting
Guy's and St Thomas' Sexual Health Clinic
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is lactoferrin?

Lactoferrin is a natural protein found in milk that helps prevent infections and supports healthy bacteria.

What's the difference between this study and a normal treatment?

This study directly compares a new treatment (lactoferrin) with standard care to see if it's equally good or better.

Will I know which treatment I'm getting?

Yes, you will know if you are getting the lactoferrin pessaries or the antibiotic/antifungal tablets.

How long will I be involved in the study?

Your involvement in the study will last for a total of 12 weeks, with follow-up appointments and home samples.

What if my infection doesn't get better?

The study team will be checking your progress, and you'll be able to discuss further treatment options if your infection doesn't clear up.

How to find out more

Pippa Oakeshott, MD

oakeshot@sgul.ac.uk 020 8725 0153 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.