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Due to high susceptibility to infections, antibiotics are the most widely used drugs for newborns. Recent evidence suggests that antibiotics exposure in newborn period (first 4 weeks of life) predisposes to an imbalance in the gut, which may have long lasting consequences. Imbalances in the infants’ gut bacteria (microbiome) caused by antibiotics has been shown to alter the development of the neonate’s immune response. This altered immune development caused by a poorly balanced microbiome during this crucial phase of early life has been associated with the development of atopy, asthma, eczema, allergy, type 1 diabetes and inflammatory bowel disease. Mucosal immunity development in the gut has been shown to be aberrant as early as one month of age in children who go on to develop allergy symptoms in future. RESTORE is a clinical trial of a multi-strain probiotic for antibiotics exposed term newborn infants with aims to restore biodiversity and reduce dysbiosis (imbalance of bacteria) in the newborn gut in early months after birth. This is the first study of its kind to examine effects of probiotics on these high-risk infants’ gut biodiversity and mucosal immune development. Research Questions 1. Can the gut microbial diversity of infants exposed to postnatal antibiotics be restored earlier (within neonatal period after birth) by daily use of multi-strain probiotic supplementation? 2. Is this effect sustained at 3 months and 12 months? 3. Can probiotics in antibiotic exposed infants improve the production of salivary and secretory IgA to that seen in infants without antibiotics exposure? Methodology This randomised control trial will be conducted at Fiona Stanley Hospital. A total of 120 term neonates will be recruited, 80 of whom would have received antibiotics at birth for clinical reasons. Forty of the antibiotic exposed neonates will receive daily probiotics for 3 months and forty infants will receive a placebo. Forty infants without antibiotic exposure will serve as a reference group. Stool, saliva and blood will collected for microbiome and/or immunological tests at five time-points in the first 12 months of life. Predicted Benefits and Relevance: Neonatal infections, antibiotic use and allergy in later life are highly relevant health issues for infants, with gut microbiome as the potential denominator. In Australia, the economic cost of allergic diseases is estimated to be >$30 billion annually. Probiotics have been extensively used to restore microbiome balance in adults and hold potential to be useful for newborns for this indication. Although some promising data exists from animal studies, No human studies have yet determined whether probiotics are effective in rapidly restoring the balance of bacteria in term neonates’ gut following exposure to antibiotics. We are proposing a randomised control trial to determine if multi-strain probiotics can rapidly normalize the infants’ microbiome following neonatal antibiotic exposure during the crucial time of immune development and improve mucosal immunity. This study will provide insights for conducting larger multicentre trial to confirm clinical benefits; which will potentially change the practice to routinely supplement these high-risk babies with probiotics in the newborn period.

The aim of the project is to evaluate the risk of antibodies to blood donor proteins developing after blood transfusions from blood donors selected to be compatible with the recipient. Participants will be patients who are planned to undergo a kidney transplant with a live donor. Testing for antibodies to donor proteins will be done before and 6-8 weeks after the transfusion to look for the development of new antibodies. This will help researchers to find a way to give patients blood transfusions without the risk of them developing antibodies that could put later transplants at risk.

The Harmony in the Bush dementia study will implement innovative strategies of an individualised care model developed based on the principles of a well-established Progressively Lowered Stress Threshold (PLST) framework for non-pharmacological care of dementia. The PLST model recognises that behavioural and psychological symptoms of dementia, such as agitation, are experienced by people with dementia and increased stress is triggered by internal and external environmental factors. These factors will be identified during the assessment phase of this research intervention, and the investigators will work with the residential aged care staff to help them modify the daily routine and implement more flexible, personalised activities of daily living including sleep. Actigraphy watches will be fitted on the wrists of participating residents living with dementia to record the sleep patterns. Collectively, these information will be used in co-designing personalised care plans based on the PLST model seven principles .This research will also expand the PLST-based personalised care model intervention, by incorporating individualised preferred music/arts and movement programs to co-design a PLST plus music/arts and movement personalised care intervention. The investigators hypothesise that these co-designed PLST-based (without and with integrated individualised preferred music/arts activities) personalised care interventions will result in a low stress organisational environment and a positive workplace culture; thus leading to improved residents with dementia outcomes such as reduced agitation level, better quality sleep and overall wellbeing, reduced caregivers stress level, and a positive change in the workplace culture.

This study will evaluate the effectiveness of using activity monitors to assess pain and physical activity in patients with advanced cancer. Who is it for? To be eligible for the study participants are to be over the age of 18 years, diagnosed with advanced cancer, are experiencing pain, and are patients at Mater Misericordaie Ltd or St Vincent's Private Hospital, Brisbane. Study Details: Participants will receive an tri- accelerometer which will be similar in size/design to a watch. Participants are to wear the monitor for the duration of the study for a total of 6 days. It will record a number of activities during this time like sleep, steps taken, body position etc. Participants will be required to keep a diary at home, where they are to complete daily pain score assessments. Participants are to return to a scheduled clinic appointment on day 7 and return tri-accelerometer and diaries. Nil follow-up regarding the trial is required; participants will continue to see the doctor as per scheduled appointments. This research will help determine whether we may assess the effectiveness of pain management programs in an objective way. This in turn will allow us to determine which pain management methods are most effective.

Elective total shoulder arthroplasty (TSA) is a common and effective orthopaedic procedure for the treatment of osteoarthritis and rotator cuff injuries. Infection remains a common reason for surgical revision. A common bacteria causing these infection is Propionibacterium Acnes. The current method to reduce post op infections is to use skin preparations prior to surgery. This standard surgical prophylaxis does not seem to decrease the bacterial load. This may be a potential source of infection for susceptible patients having procedures with surgical implants. Benzyl Peroxide (BPO) and Benzyl Peroxide/Clindamycin (BPO/C) topical skin preparations have been shown to reduce the superficial skin colonization of P. acnes. This study aims to investigate the use of BPO and BPO/C as a topical skin preparation and to determine the effects it has in reducing positive cultures in patients undergoing TSA. Study Outcomes • Contamination and inoculation with P. Acnes will be determined via microbiological analysis. Positive cultures will be noted and compared statistically between groups. From this data efficacy between preparations can be determined. • Compliance with the various skin preparations will be completed at the 2 week follow-up via survey.

The purpose of the study is to see whether the antibiotic combination of 100mg doxycycline, 500mg azithromycin and 300mg rifabutin is a safe and effective treatment for coronary artery disease which has not responded to "standard" treatment. Coronary artery disease is the process of plaque build up within the walls of the arteries responsible for the supplying the heart with oxygen and nutrients. Plaque is usually made up of fatty deposits, minerals and various amounts of tissue and white cells which eventually narrows the artery, reducing blood flow to the heart. The resulting damage and build up of fat results in inflammation of the arterial wall and eventually the arteries narrow. The researchers involved in this study consider that a pathogen called Chlamydophila pneumonia, which can live inside cells, may cause this inflammation of the arterial wall. The purpose of this study is to see if treatment with this antibiotic combination in patients with CHD is safe and effective in reducing disease severity measured at coronary angiography and improving quality-of-life. Approximately 60 patients will be involved in this trial. The treatment period is 90 days, with a further 90 day follow-up period.

Background: Although Negative Pressure Wound Therapy (NPWT) has become widely used in the management of several wound types, its efficacy as a primary therapy for acute burns has never been adequately investigated, with research in children particularly lacking. There is limited evidence, however, that NPWT might benefit paediatric burns patients, amongst whom scar formation, wound progression, and pain continue to present major management challenges. The purpose of this trial is to determine whether NPWT in conjunction with standard therapy accelerates healing, reduces wound progression, and decreases pain more effectively than routine treatment alone. Methods: A total of 96 paediatric burns patients will be recruited for this trial. To be eligible, candidates must be under 17 years of age and present with a thermal burn covering <5% of their total body surface area to the participating children’s hospital within 7 days of their injury. Facial and trivial burns will be excluded. Following a randomised controlled, parallel design, participants will be allocated to either an active control or intervention group. The former will receive standard therapy consisting of Acticoat™ and Mepitel™, secured with Hypafix™. The intervention arm will be treated with silver-impregnated dressings in addition to NPWT via the RENASYS TOUCH™ vacuum pump. Participants will undergo dressing changes every 3-5 days until the point of healing. The primary endpoint will be time to re-epithelialisation. Secondary outcomes include pain, pruritus, wound progression, cost effectiveness, ease of management, treatment satisfaction, and adverse events. A linear mixed model will be performed to determine the evolution across time and between groups in primary and secondary outcomes, with patients as random effect. Wound fluid collected during NPWT will also be analysed to generate a proteomic profile of the burn microenvironment. Discussion: The study will be the first randomised controlled trial to explore the effects of NPWT on paediatric burns, with the aim of determining whether the therapy warrants implementation as an adjunct to standard burns management.

Gluteal tendinopathy (GT) is a common, debilitating musculoskeletal condition, most often seen in middle aged females, and sedentary overweight people. The resultant lateral hip pain leads to reduction in physical activity and often poor sleep, which may impact on general health and well-being, as well as quality of life and employment status. It has been proposed that compressive loading is a factor that contributes to the development of insertional tendinopathy. Compressive loading of the gluteal tendons occurs between the iliotibial band (ITB) and the greater trochanter in positions of hip adduction. Daily postures, such as sitting with knees crossed, standing ‘hanging on one hip’ in adduction, and side-lying, may contribute to cumulative compression on the tendons. The impact of this can be imparted to the patient through education, which has been proposed as a key component of load management. Tendon loading can be controlled by postural changes, avoidance of aggravating activities, and regulation of physical activity volumes and intensities. Most literature suggests a multimodal program of education in addition to appropriate exercise prescription. A randomized controlled trial recently demonstrated that a multimodal load management program in the form of advice and practical strategies in addition to exercises in GT was superior in terms of pain reduction and perceived rating of improvement in the overall condition to corticosteroid injection or a wait and see approach in both the short and long term. To date, the impact of load management through education alone has not been investigated. Therefore, the primary aim of this study is to: 1.Investigate the efficacy of online education/information material on global rating of change in individuals with gluteal tendinopathy. The secondary aims of this study are to: 2. Evaluate the patients’ perceptions of the education brochure by assessing quantitative and qualitative questionnaires at 6 weeks. 3. Assess possible prognostic variables of pain and disability for gluteal tendinopathy at 12 months

Annually, hundreds of thousands of people survive a life threatening event/illness and require admission to an intensive care unit. Many of those will experience significant and life changing psychological complications as a result. There are no evidence based recovery programs available within Australia or throughout the world which could help reduce the risk of these complications developing. This intervention study will evaluate a mobile health (m-health) recovery program by measuring the emotional and psychological well-being of participants over time. Outcome measures will include incidence and severity of anxiety and depression, Post-Traumatic Stress Disorder and health related quality of life.

Aim: To demonstrate the usefulness of two tests for laryngopharyngeal reflux (pH/Impedance and Oral Pepsin ELISA) Participants: 50 adults (>18 years) with a clinical diagnosis of laryngopharyngeal reflux (LPR) presenting to ENT/laryngology clinic. Method: Informed consent will be gained from participants, who will be asked to first complete two forms related to their experience of reflux (Belafsky Reflux Symptom Index (RSI)& Vocal Tract Discomfort Scale). Participants will then have a 24­hour dual pH/Impedance probe placed in clinic, confirmed by either manometry (preferred) or direct visualised pullback (DVP) method ­ depending on final departmental budgeting. During this 24 hr period, up to 5 salivary samples will also be collected: 1x upon waking and standing but before breakfast and teeth­brushing, 1x 60minutes after lunch and 1x 60 minutes after dinner. The fourth and fifth samples may be collected following symptoms being experienced by the patient. After 24 hours the probe will be removed and the salivary samples will be returned to the clinic, refrigerated at 4 degrees and analysed within 2 days. We expect to see increased diagnostic value of combing the results of these two tests.