A randomised controlled trial of lactobacillus in general practice to prevent post-antibiotic vulvovaginitis
| ISRCTN | ISRCTN24141277 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24141277 |
| Secondary identifying numbers | 2001/524 (number assigned by the Therapeutic Goods Administration in Australia) |
- Submission date
- 08/10/2002
- Registration date
- 08/10/2002
- Last edited
- 07/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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
Contact information
Dr Jane Gunn
Scientific
Scientific
Department of General Practice
200 Berkeley Street
Carlton
3053
Australia
| Phone | +61 (0)3 8344 4530 |
|---|---|
| j.gunn@unimelb.edu.au |
Study information
| Study design | Randomised controlled blinded 2 x 2 factorial design, with four intervention groups |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Lactobacillus |
| Primary outcome measure | 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 |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/07/2004 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Australia
Study participating centre
Department of General Practice
Carlton
3053
Australia
3053
Australia
Sponsor information
University of Melbourne (Australia)
University/education
University/education
-
Victoria
3010
Australia
| Website | http://www.unimelb.edu.au |
|---|---|
"ROR" |
https://ror.org/01ej9dk98 |
Funders
Funder type
Charity
Shepherd Foundation (Australia)
No information available
Royal Australian College of General Practitioners (Australia) (ref: 00/58)
Private sector organisation / Associations and societies (private and public)
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- RACGP
- Location
- Australia
Department of Health and Aged Care (Australia) - scholarship for Dr Pirotta
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 28/03/2004 | Yes | No |
