Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:17 PM
Ignite Modification Date:
2025-12-24 @ 9:17 PM
NCT ID:
NCT05434104
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
50 Years
Study:
NCT05434104
Study Brief:
Protocol Section:
NCT05434104