Status:
UNKNOWN
The LISA (Lactoferrin InStead of Antibiotics/Antifungals) Feasibility Study
Lead Sponsor:
St George's, University of London
Collaborating Sponsors:
King's College London
Statens Serum Institut
Conditions:
Bacterial Vaginosis
Candida Vaginal
Eligibility:
FEMALE
16-50 years
Phase:
NA
Brief 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 ...
Detailed Description
Research Question: Is it feasible to conduct a future trial to investigate if Lactoferrin is an acceptable alternative to oral antibiotics/antifungals for women with bacterial vaginosis or thrush? Bac...
Eligibility Criteria
Inclusion
- 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
- 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
- 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)
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT05434104
Start Date
October 1 2022
End Date
June 1 2024
Last Update
October 13 2022
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
St Thomas' NHS Trust
London, United Kingdom, se1 7eh
2
St George's, University of London
London, United Kingdom, SW17 ORE