ANZCTR search results

The human digestive tract, especially the gut, is populated by millions of microorganisms including bacteria, and fungi, the so-called microbiome. Many studies have shown that the microbiome is linked to health from digestive disorders, to heart health, or mental health. The microbiome can be modified by your diet, and probiotics are frequently advertised to alter the gut microbiome. One such product is kefir, a probiotic dairy beverage that has been consumed for over 2,000 years. Traditional kefir is produced by taking for example cow’s milk, and adding Kefir ‘grains’ which contain a diverse range of symbiotic bacteria and yeast species. Anecdotal statements in the media continue to link the consumption of Kefir to gut health, despite a lack of scientific evidence to support this. In order to advance the scientific understanding of Kefir, this study aims to examine whether kefir consumption leads to changes in the oral and gut microbiome, i.e. the bacteria living in the digestive tract. It is hypothesised, that kefir will increase the number of beneficial bacteria in the mouth and gut.

This study aims to explore the impact of home-based exercise sessions supervised via telehealth on the health and fitness of people with breast cancer. Who is it for? You may be eligible for this study if you are an adult aged 18 or over who has been diagnosed with breast cancer, have recently completed anti-cancer therapy, and have a risk of heart damage. Study details All participants will undertake remotely-monitored aerobic exercise sessions at home (e.g., walking, cycling), 3 times per week over 8 weeks. The session length and exercise intensity will be individualised for each participant. Participants will also be provided with general exercise education, and learn about behaviour change through the study mobile application. Participants will be asked to attend three study appointments to complete a questionnaire and undertake a cardiopulmonary exercise test. Each visit with take approximately 75 minutes (15 minutes for the questionnaire and 60 minutes for the exercise test). The visits occur before the study, after 2 months, and after 5 months. It is hoped that this research will help determine if home-based exercise supervised via telehealth in real time is safe and effective in improving the health and fitness of breast cancer patients.

Bronchiolitis is a common viral infection of the small airways of infants and some affected infants will require hospital admission. Severe bronchiolitis is a marker for greatly increased risk of developing both preschool wheeze and subsequent school age asthma. Since epidemiological studies suggest that exposure to microbial products protects against preschool wheeze, lysates of bacteria may prevent the development of wheeze after bronchiolitis, with long-term beneficial consequences. BLIPA is a phase IIb, randomised, double blind, placebo-controlled study, investigating the efficacy superiority of bacterial lysate (Broncho Vaxom) capsules over placebo, in reducing wheeze in infants after severe bronchiolitis. The primary end point of the study is rate of parent-reported wheeze episodes. The study aims to test bacterial lysate capsules (3.5mg over 12-24 months) for safety, efficacy, and to advance mechanistic understanding of its action.

This study examines whether a virtual reality experience can be used to prepare children aged 4- 10 years age for magnetic resonance imaging scans. Magnetic resonance imaging (MRI) is an important type of medical imaging frequently used in paediatric care. Successful image acquisition needs children to enter and lay still in a narrow tunnel for 30-60 minutes. This environment can be anxiety provoking for children, and some children will refuse to lie on the magnetic resonance imaging table. This study examines whether a virtual reality (VR) experience can be used to prepare children aged 4- 10 years age for magnetic resonance imaging scans.

This study seeks to explore the health-related beliefs, motivations, skills and support needs of people who access online psychological treatment for depression and/or anxiety, and how these influence whether and how people engage with and respond to treatment. There is already a lot of research to support the safety, acceptability, and effectiveness of online psychological treatments for adults with depression and/or anxiety. Now, we wish to build our understanding about how different people may engage with and respond to treatment differently, so that we can develop practical strategies and supports to help people engage in way that best suits their needs and priorities. To do this, we will recruit adults both in Australia and overseas with depression and/or anxiety and if eligible, randomly allocate them to receive treatment either straightaway or after an 8-week delay (waitlist control). We will ask participants to complete questionnaires when they apply for treatment, before starting treatment, mid-way through treatment, and after finishing treatment. Australian participants who enrol in treatment will also be asked to participate in an optional interview asking about their views and experience of deciding to take-up online psychological treatment. It is expected that participants reporting lower health literacy levels in their application will have higher levels of depression and anxiety at all time-points (before, during, and after treatment), and will be less likely to take-up and complete treatment.

This study will assessing the clinical utility of a calculated Survival Score Index for Implantable Cardioverter Defibrillator patients having had device battery replacement or palliative care at the Royal Adelaide Hospital. This study will retrospectively assess clinical parameters for patients who meet study inclusion citeria to allow calculation of a score for each individual, which will then be combined for group analysis of patients who had an intervention of battery replacement, or elective palliative deactivation of their device during the 5-year study period up until 31st December 2020.

[ Why Are We Doing This Research? ] The purpose of this study is to implement and test the effectiveness of a new care model that will be coordinated by specialist cancer nurses while also involving medical specialists (surgeons, oncologists, and general practitioners/GPs) for follow-up care of people with prostate cancer. [ Who Is It For? ] You may be eligible for this study if you are aged 18 or older and have prostate cancer. [ Study Details ] Participants in this study will be randomly allocated to one of two groups. Participants in one group will be receiving usual, specialist-led follow-up care and information from Cancer Council Australia for up to 5 years. The other group will undergo the nurse-coordinated care model. This involves a series of 30-to-60-minute appointments with specialist nurses, GPs, or hospital cancer specialists every 6 months, for up to 5 years. As part of the study all participants will answer a series of questionnaires at baseline, 6 months, and 12 months. It is hoped this research will demonstrate that the new model of care increases patient quality of life and health care experience and improve prostate cancer follow-up care.

In this randomised, double-blind, parallel-group, placebo-controlled study, 120 overweight/ mildly obese adults (body mass index between 25 and 35 kg/m2) experiencing high stress and low energy will be randomly assigned into one of two groups comprising either a twice-daily intake of capsules containing a Withania somnifera (Ashwagandha) extract or a placebo for 12 weeks. We will assess changes in stress, fatigue, quality of life, and interest in sexual activity using several self-report questionnaires. Changes in sex hormone concentrations, oxidative stress, inflammation, blood glucose regulation will be assessed from a venous blood collection. A blood sample will also be collected to measure changes in liver and renal function, and complete blood count. Changes in heart rate variability will also be assessed over time. Finally, changes in strength will be determined using a hand-held dynamometer, which is an indicator of overall body strength. It is hypothesised that, compared to the placebo, ashwagandha supplementation will be associated with a greater reduction in stress, improvements in energy, quality of life, and endocrine/ physiological markers.

The main aim of this study program will be to develop the current understanding of the chronic stress response to a non-severe burn injury (less than or equal to 20% total body surface area (TBSA)) in adult patients, with the addition of the novel approach of metabolic flexibility assessment to better characterise this response. Specifically, we aim to determine the interaction of the systemic metabolic, inflammatory, musculoskeletal and cardiovascular responses, aiming to present a compete image of the chronic response post non-severe burn injury, as well as the effects of common treatments in the form of surgery and nutritional support. The primary objective of this study will be to determine the state of metabolic flexibility in acute non-severe burned patients (less than or equal to 20% TBSA) across a 12-month period of analysis of recovery at four time points. Secondary objectives of this study will be to analyse the acute stress response of non-severely burned patients across the same 12 month period post injury, looking specifically at metabolic, inflammatory, musculoskeletal and cardiovascular responses, as well as to examine the acute effects of surgical intervention on metabolic rate in non-severely burned patients. We hypothesise that non-severely burned patients will experience a state of metabolic inflexibility throughout their post injury recovery, while also displaying a similar physiological stress response to what is seen in larger burns injuries.

The main purpose of this study is to investigate the feasibility of Stereotactic Ablative Body Radiation (SABR), a method of delivering palliative radiotherapy, for patients with head and neck cancers. Who is it for? You may be eligible for this study if you are an adult aged 18 or older, you have been diagnosed with either primary head and neck cancer, or another cancer that has metastasized to your head and neck, and you have been assessed as unsuitable for curative-intent surgery and/or radiotherapy by the Head and Neck multidisciplinary team. Study details Participants who choose to enrol in this study will undergo a series of 5 radiotherapy treatment sessions over two weeks, with a minimum of 48 hours between each session. After the treatment sessions your radiation oncologist and the study team will follow up at 3 monthly intervals intervals to examine any side effects, the overall effectiveness and your quality of life. All participants will be assessed at regular intervals post treatment for up to two years. It is hoped this research will provide more knowledge and understanding of the use of SABR in head and neck cancers in Australia. This information may then be used to improve health outcomes for future patients with head and neck cancers