A randomised controlled trial of lactobacillus in general practice to prevent post-antibiotic vulvovaginitis
- Conditions
- Post-antibiotic vulvovaginitisInfections and Infestations
- Registration Number
- ISRCTN24141277
- Lead Sponsor
- niversity of Melbourne (Australia)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 496
1. Women aged between 18 and 50 years of age
2. Who are experiencing a non-genital infection
3. Rrequiring a short-course of oral antibiotics or have commenced this within the 48 hours preceding enrolment
4. English-speaking: able to speak, read and write in English sufficiently to provide informed consent and complete surveys
1. Pregnancy
2. Experiencing any vaginal symptoms at recruitment
3. Unwilling or unable to provide two self-collected low vaginal swabs (at recruitment and on completion of trial)
4. Using or have used vaginal antifungal treatments in the past two weeks
5. Have taken antibiotics in the past month
6. Unwilling to stop taking other lactobacillus products during the trial
7. Immunocompromised, as there are rare reports in the literature of lactobacilli causing endocarditis and bacteraemia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is symptomatic vulvovaginal candidiasis, defined as:<br>1. Participants' report of symptoms (that is answer 'yes' to a question about symptoms of 'thrush' in survey 2: vaginal itch, irritation with or without a discharge) <br>2. Swab B culture positive for Candida species
- Secondary Outcome Measures
Name Time Method o secondary outcome measures