The LISA (Lactoferrin InStead of Antibiotics/Antifungals) Feasibility Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16-50
SponsorGuy's and St Thomas' NHS Foundation Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 16-49 years
Having periods (apart from women with a Mirena IUCD or polycystic ovary syndrome)
Ability to consent
Clinical diagnosis of BV or thrush confirmed on Gram stain
Disqualifiers
Pregnant or breast feeding
Currently has chlamydia, gonorrhoea or trichomonas (as treatment for these would affect the results).
Known allergy to metronidazole or azoles
Post-menopausal (because of diagnostic confusion between atrophic vaginitis and bacterial vaginosis)
Trial design
Design model
Parallel
Treatments tested in this trial
Vaginal lactoferrin
Other interventionLactoferrin vaginal pessaries to insert nightly for 21 nights
Usual care
DrugWomen with bacterial vaginosis will be given oral metronidazole and women with vaginal candida will be given oral fluconazole
Treatment groups
114 Participants
are divided into 2 treatment groupsGroup A: Lactoferrin intervention groupExperimental treatment 1 intervention
Group B: Usual care control - standard oral antibiotics/antifungalsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The acceptability of vaginal lactoferrin treatment
This will be assessed from interviews with 15-20 participants
Time frame
4-16 weeks after recruitment2
Adherence to treatment
This will be assessed from participants' weekly count of remaining pessaries/tablets from questionnaires at 1, 2, 3 and 4 weeks
Time frame
During the first 4 weeks of the study3
Recruitment rate
Investigators will record the percentage of eligible women who agree to take part
Time frame
Up to 15 months4
Follow-up rate
Investigators will record the percentage of randomised women who are followed up after 12 weeks
Time frame
Up to 20 monthsSecondary outcomes
1
Acceptability of study procedures, and whether participants think other women would be willing to take part in a future randomised trial of lactoferrin versus oral antibiotics.
Investigators will conduct telephone interviews between 4 and 16 weeks after recruitment with 15-20 participants
Time frame
4-16 weeks after recruitment2
Adverse events such as nausea, vomiting, vaginal irritation, abdominal pain, rashes, diarrhoea
Investigators will ask about adverse events during weekly text questionnaires during the first four weeks and on the final questionnaire at 12 weeks follow up
Time frame
Between recruitment and 12 week follow up3
Recurrence or persistence of infection by 12 weeks
Investigators will ask about symptoms of infection on the final 12 week questionnaire and assess infection status by analysis of self-taken vaginal samples
Time frame
At 12 week follow up4
Feasibility of obtaining data on healthcare use
This will be assessed by comparing reported healthcare use in final 12 week questionnaires with a medical record search in 30 participants
Time frame
Last 6 months of studySponsors and contacts
Click on the lead sponsor to view all of their trials.
Guy's and St Thomas' NHS Foundation Trust
Lead sponsor
King's College London
Collaborator
Statens Serum Institut
Collaborator
Source ClinicalTrials.gov