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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
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 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
Participation Requirements
Sex: Female
Minimum Age: 16
Maximum Age: 50
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
United Kingdom
Guy's and St Thomas' Sexual Health Clinic
RECRUITING
London
St Thomas' NHS Trust
NOT_YET_RECRUITING
London
Contact Information
Primary
Pippa Oakeshott, MD
oakeshot@sgul.ac.uk
020 8725 0153
Backup
Fiona Reid, MSc
fiona.reid@kcl.ac.uk
Time Frame
Start Date: 2026-04-16
Estimated Completion Date: 2027-12
Participants
Target number of participants: 114
Treatments
Experimental: Lactoferrin intervention group
Women will be given bovine lactoferrin 300mg vaginal pessaries to insert every evening for the first 21 days of the study \[25\].
Active_comparator: Usual care control - standard oral antibiotics/antifungals
Control women with BV will be given oral metronidazole 400mg twice daily for five days (and routine advice about avoiding alcohol). Control women with candida will be given a fluconazole 150mg capsule to take orally the same day.
Related Therapeutic Areas
Sponsors
Leads: Guy's and St Thomas' NHS Foundation Trust
Collaborators: Statens Serum Institut, King's College London

This content was sourced from clinicaltrials.gov