Is the Naturally Occurring Prebiotic Lactoferrin an Acceptable Alternative to Antibiotic/Antifungal Tablets for Women With Bacterial Vaginosis or Thrush?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- The acceptability of vaginal lactoferrin treatment
研究概览
简要总结
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.
详细描述
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? Background Over 200,000 women are affected by bacterial vaginosis (BV) or vaginal candida/thrush each year in England. A million women suffer recurrent infections which many find distressing. The infections may also be associated with HIV infection and adverse pregnancy outcomes. Although BV and candida can be treated with oral antibiotics/antifungals, these can have side effects and encourage the development of antimicrobial resistance, a major global health problem.
Lactoferrin is a naturally occurring prebiotic protein present in the vagina where it helps to prevent infections and normalise the vaginal microbiome. It has been used to treat refractory BV and may also be effective against candida, but more evidence is needed.
Objective To see if it is feasible to conduct a future, definitive trial in women with BV or candida to investigate if vaginal lactoferrin pessaries are as effective as oral antibiotics in resolving symptoms, preventing recurrent infection and producing a healthy lactobacilli-dominated vaginal microbiome.
Design: open label randomised feasibility study over 12 weeks with qualitative, economic and microbiological evaluations.
Setting: a sexual health clinic and a general practice
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
This is an open label trial and there will be no blinding to treatment allocation of the participants or researchers. However, the analysis of samples (Gram stain and microbiome analysis) will be done blind to treatment allocation
入排标准
- 年龄范围
- 16 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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)
研究组 & 干预措施
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].
干预措施: Vaginal lactoferrin (Other)
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.
干预措施: Usual care (Drug)
结局指标
主要结局
The acceptability of vaginal lactoferrin treatment
时间窗: 4-16 weeks after recruitment
This will be assessed from interviews with 15-20 participants
Adherence to treatment
时间窗: During the first 4 weeks of the study
This will be assessed from participants' weekly count of remaining pessaries/tablets from questionnaires at 1, 2, 3 and 4 weeks
Recruitment rate
时间窗: Up to 15 months
Investigators will record the percentage of eligible women who agree to take part
Follow-up rate
时间窗: Up to 20 months
Investigators will record the percentage of randomised women who are followed up after 12 weeks
次要结局
- Acceptability of study procedures, and whether participants think other women would be willing to take part in a future randomised trial of lactoferrin versus oral antibiotics.(4-16 weeks after recruitment)
- Adverse events such as nausea, vomiting, vaginal irritation, abdominal pain, rashes, diarrhoea(Between recruitment and 12 week follow up)
- Recurrence or persistence of infection by 12 weeks(At 12 week follow up)
- Feasibility of obtaining data on healthcare use(Last 6 months of study)
- Percent of self-taken samples suitable for microbiological analysis(During the 12 weeks after recruitment)
- Percentage of participants who complete weekly symptom questionnaires for the first four weeks after recruitment.(During the 12 weeks after recruitment)