Plain language statement

PAV Study for Women’s Health

Plain language statement Vaginal candidiasis or thrush is a very common and irritating problem for many women. It may cause symptoms of vaginal itch and irritation and/or discharge. Your general practice is working with the University of Melbourne in research to try to improve women’s health by testing a commonly used alternative therapy for thrush - lactobacillus. • • •

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This trial will test lactobacillus (the bacterial culture used in some yoghurts) by mouth and vaginal pessary against inactive (placebo) forms to see if it will prevent thrush after antibiotics. You have a 1 in 4 chance of being given an inactive form of both powder and pessary. Your doctor will care for you in the usual manner, whether you choose to participate in the trial or not. Your participation would be voluntary and you would be free to withdraw from the study at any time. To participate, you will be asked to a) fill in an anonymous survey, mainly to help us understand if you are more prone to thrush than most women, b) take a swab from your vagina yourself in private in the clinic (to find the women who carry thrush in their vagina with no symptoms before commencing the antibiotics) c) use a powder mixed in water by mouth twice a day and a vaginal pessary overnight for ten days d) obtain a second swab and answer a second anonymous survey when you finish your course of lactobacillus. The second questionnaire will mainly ask about any problems with the treatment. If you develop any symptoms of thrush, you should contact your GP. Please DO NOT treat yourself before a swab has been taken. Your GP will be able to access the results of your swabs. Although unlikely, it is possible that some women may have side-effects from the treatments. The powder may cause tummy bloating or changes in bowel habit. Occasionally women experience an excessive increase vaginal discharge, which stops when the pessaries are finished. If you have any concerns or side-effects from the pessaries, please stop using them and contact Dr Marie Pirotta on 0417 102 643. The information obtained from this trial will be treated as confidential and only seen by the researchers at the University of Melbourne, that is not by the staff in your clinic. Information from the surveys will be kept confidential subject to legal requirements and then will be destroyed after five years. If you decide not to participate, your doctor will ask permission to record anonymously a few details about you. This is to ensure that the women entering the trial are similar to the women who do not take part.

Thank-you for your time, Dr Marie Pirotta GP and PhD student If you have any concerns about the conduct of this study, please contact the Executive Officer, Human Research Ethics, The University of Melbourne, 8344 7507. This research is being conducted by Drs Marie Pirotta and her supervisors and co-investigators Drs Jane Gunn, Sonia Grover and Prof Suzanne Garland through the Department of General Practice. The research is funded through the Shepherd Foundation, the Royal Australian College of General Practitioners and a scholarship from the Dept of Health and Aged Care.