A randomised controlled trial of lactobacillus in general practice to prevent post-antibiotic vulvovaginitis

ISRCTN	ISRCTN24141277
DOI	https://doi.org/10.1186/ISRCTN24141277
Protocol serial number	2001/524 (number assigned by the Therapeutic Goods Administration in Australia)
Sponsor	University of Melbourne (Australia)
Funders	Shepherd Foundation (Australia), Royal Australian College of General Practitioners (Australia) (ref: 00/58), Department of Health and Aged Care (Australia) - scholarship for Dr Pirotta

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Jane Gunn
Scientific

Department of General Practice
200 Berkeley Street
Carlton
3053
Australia

Phone	+61 (0)3 8344 4530
Email	j.gunn@unimelb.edu.au

Primary study design	Interventional
Study design	Randomised controlled blinded 2 x 2 factorial design, with four intervention groups
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	PAV (post-antibiotic vulvovaginitis)
Study objectives	This study aims to test in a randomised controlled trial whether oral and/or vaginal lactobacillus preparations can prevent post-antibiotic vulvovaginitis.
Ethics approval(s)	The trial has received ethics approval from both the Royal Australian College of General Practitioners and the Royal Women's Hospital, Melbourne, Australia.
Health condition(s) or problem(s) studied	Post-antibiotic vulvovaginitis
Intervention	Factorial design to test oral and vaginal lactobacillus species.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Lactobacillus
Primary outcome measure(s)	The primary outcome is symptomatic vulvovaginal candidiasis, defined as: 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) 2. Swab B culture positive for Candida species
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	496
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	01/07/2004
Date of final enrolment	31/12/2005

Department of General Practice

Carlton
3053
Australia

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	Protocol	28/03/2004		Yes	No