[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100472609":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":48,"responsibleParty":79,"collaborators":81,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":43,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":68,"whyStopped":43,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Guy's and St Thomas' NHS Foundation Trust","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lactoferrin intervention group","EXPERIMENTAL","Women will be given bovine lactoferrin 300mg vaginal pessaries to insert every evening for the first 21 days of the study \\[25\\].",[13],"Other: Vaginal lactoferrin",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual care control - standard oral antibiotics\u002Fantifungals","ACTIVE_COMPARATOR","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.",[19],"Drug: Usual care",[21,27],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Vaginal lactoferrin","Lactoferrin vaginal pessaries to insert nightly for 21 nights",[9],[26],"Difesan vaginal pessaries",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Usual care","Women with bacterial vaginosis will be given oral metronidazole and women with vaginal candida will be given oral fluconazole",[15],[33],"Oral metronidazole or fluconazole",[35],{"name":36,"affiliation":37,"role":38},"Pippa Oakeshott, MD","St George's, University of London","PRINCIPAL_INVESTIGATOR",[40,45],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","020 8725 0153",null,"oakeshot@sgul.ac.uk",{"name":46,"role":41,"phone":43,"phoneExt":43,"email":47},"Fiona Reid, MSc","fiona.reid@kcl.ac.uk",[49,66],{"facility":50,"status":51,"city":52,"state":43,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"St Thomas' NHS Trust","NOT_YET_RECRUITING","London","se1 7eh","United Kingdom","UK",{"type":57,"coordinates":58},"Point",[59,60],-0.12574,51.50853,{"lat":60,"lon":59},[63],{"name":64,"role":41,"phone":43,"phoneExt":43,"email":65},"Phillip Hay, FRCP","phillip.Hay@gstt.nhs.uk",{"facility":67,"status":68,"city":52,"state":43,"zip":43,"country":54,"countryCode":55,"cosmosGeoPoint":69,"geoPoint":71,"contacts":72},"Guy's and St Thomas' Sexual Health Clinic","RECRUITING",{"type":57,"coordinates":70},[59,60],{"lat":60,"lon":59},[73,77],{"name":74,"role":41,"phone":75,"phoneExt":43,"email":76},"Lauren Martinez","07860941420","laurenmartinez@nhs.net",{"name":78,"role":38,"phone":43,"phoneExt":43,"email":43},"Phillip Hay, MD",{"type":80,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[82,84],{"name":83,"class":6},"King's College London",{"name":85,"class":6},"Statens Serum Institut","100472609","the-lisa-lactoferrin-instead-of-antibioticsantifungals-feasibility-study-100472609",false,"NCT05434104","The LISA (Lactoferrin InStead of Antibiotics\u002FAntifungals) Feasibility Study","Is the Naturally Occurring Prebiotic Lactoferrin an Acceptable Alternative to Antibiotic\u002FAntifungal Tablets for Women With Bacterial Vaginosis or Thrush?","LISA","Inclusion Criteria:\n\n* Aged 16-49 years\n\n  * Having periods (apart from women with a Mirena IUCD or polycystic ovary syndrome)\n  * Ability to consent\n  * Clinical diagnosis of BV or thrush confirmed on Gram stain\n  * Willing to be randomised to vaginal lactoferrin pessaries or oral antibiotics\u002Fantifungals\n  * Agrees to provide vaginal samples at home and post\u002Fdeliver them back to the research team.\n  * Agrees to avoid douching during the study (as this can flush out lactobacilli needed for a healthy microbiome).\n\nExclusion Criteria:\n\n* Pregnant or breast feeding\n* Currently has chlamydia, gonorrhoea or trichomonas (as treatment for these would affect the results).\n* Known allergy to metronidazole or azoles\n* Post-menopausal (because of diagnostic confusion between atrophic vaginitis and bacterial vaginosis)","FEMALE","16 Years","50 Years",{"count":98,"type":99},114,"ESTIMATED","INTERVENTIONAL",[102],"NA","Three-quarters of women have bacterial vaginosis (BV) or vaginal thrush\u002Fcandida 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.\n\nLactoferrin 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.\n\nAim 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.\n\nMethods 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\u002Fantifungal 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.\n\nOutcome measures:\n\n* Acceptability and use of vaginal lactoferrin - from questionnaires, and interviews with 15-20 women\n* Recruitment and follow-up rates\n* Cost of lactoferrin treatment\n* The percentage of women who report their symptoms have resolved after a week\n* How quickly infections clear or recur - from analysis of samples\n\nPatient benefit:\n\nIf 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.",[105,106],"Bacterial Vaginosis","Candida Vaginal",[108,109],"lactoferrin","prebiotic","2026-05-27",{"date":112,"type":113},"2026-05-29","ACTUAL",{"date":115,"type":113},"2026-04-16",{"date":117,"type":99},"2027-12",{"name":5,"class":6},2]