Is the Naturally Occurring Prebiotic Lactoferrin an Acceptable Alternative to Antibiotic/Antifungal Tablets for Women With Bacterial Vaginosis or Thrush?

What this Trial Is About

This research aims to explore whether vaginal lactoferrin pessaries can be an acceptable and effective alternative to oral antibiotics or antifungals for women with bacterial vaginosis (BV) or thrush. These infections affect many women, causing symptoms like abnormal discharge, soreness, itching, and unpleasant smell, which can impact quality of life and sexual relationships. The study also addresses concerns about antibiotic side effects and resistance. It is an open-label, randomized feasibility trial conducted in sexual health clinics and general practice settings. Women diagnosed with BV or thrush will be randomly assigned to one of two groups. One group will use vaginal lactoferrin pessaries (300 mg) every night for 21 days, while the other will take standard oral treatments: metronidazole for BV or fluconazole for thrush. The study includes repeated collection of vaginal samples and symptom tracking via texts to monitor treatment effects and infection recurrence over a 12-week period. Participants will provide self-taken vaginal samples and complete questionnaires about their symptoms and treatment experience. Follow-up visits will occur at 3 and 12 weeks for clinical checks. Researchers will measure treatment acceptability, adherence, recruitment and follow-up rates, symptom resolution, infection clearance or recurrence, adverse events, and cost-effectiveness. This trial will help determine if a larger study is feasible and may lead to new treatment options that reduce antibiotic use and resistance.

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