ANZCTR search results

Background Probiotics significantly reduce the risk of death, and serious complications (e.g. necrotising enterocolitis- an inflammatory bowel condition with high risk of death and disability, and hospital acquired infections), and improve nutrition in premature babies. However, despite the overwhelming evidence, acceptance of probiotics as a standard of care for premature babies has been slow considering the associated risks including infection due to probiotic bacteria, development of antibiotic resistance, and altered immune responses. Emerging evidence indicates that heat inactivated/killed probiotic bacteria (‘Paraprobiotics’) may provide a safe and effective alternative to probiotics (live bacteria) by overcoming their risks while retaining their benefits. Objectives The objectives of our novel pilot study comparing paraprobiotic vs. probiotic focus on finding a safe and effective alternative to probiotics. Results of our study have the potential to guide research on paraprobiotics for reducing death and disability in a wide range of population across the world (e.g. mature infants with surgical conditions of the intestine, children with inflammatory bowel disease, and immunocompromised adults) where probiotics are not used or evaluated due to their risks. Trial plan This pilot double blinded randomized controlled trial will be conducted over a period of 12-18 months (May 2018- November 2019) at King Edward Memorial Hospital. Very preterm infants < 32 weeks with specified inclusion and exclusion criteria will be recruited. Approval will be obtained from the KEMHW ethics committee. Therapeutic Goods Administration (TGA) and Clinical Trial Notification (CTN) approval will be obtained for importing the live and heat inactivated/killed probiotics from Japan. The trial protocol will be registered with the Australia New Zealand Clinical Trial Registry. Specified primary and secondary outcomes (clinical and laboratory based) will be measured.

The proposed pilot group randomised controlled trial will test the effects of cognitively engaging physical activities on executive functions, frontal lobe EEG activity and habitual physical activity in 4-5 year-old preschool children (n = 30 in intervention group; n = 30 in control group). It is hypothesised that cognitively engaging physical activities will improve executive functions and increase frontal lobe EEG activity in preschool children.

Acute, non-traumatic, low back pain is one of the most common musculoskeletal complaints worldwide and affects people of all ages. Although the majority of these individuals present to a primary care provider for assessment and management of their pain, a large proportion present to the emergency department (ED), especially when conventional analgesia is not working. Research suggests that low back pain is one of the leading causes of ED visits worldwide. While simple analgesics, opioids and muscle relaxants are commonly used to provide relief, there is little evidence to support the efficacy of these treatments. Accordingly, the management of acute low back pain in the ED represents a real challenge to clinicians. Cannabidiol (CBD), a major non-psychotropic constituent of Cannabis, has pharmacological actions as an anxiolytic, antipsychotic, antiemetic and anti-inflammatory. There are data indicating that CBD and its analogues may be beneficial for pain resulting from inflammation. In addition, CBD has considerable efficacy in managing the pain and spasm of patients with multiple sclerosis. Despite these data, no randomized, placebo-controlled trials have been undertaken to assess the utility of CBD for the treatment of acute back pain. In this study, patients presenting to the Austin ED with a diagnosis of acute (or acute-on-chronic), non-traumatic, low back pain will be randomized to either a single dose of CBD or placebo. This will be as an adjunct to the standard ED medication regimen for this condition. A verbal numerical pain scale (range 0-10) will be used to record pain scores at triage and at 0, 30, 60 and 120 minutes post study drug administration and at ED discharge. Patients may be admitted to the short stay unit during their stay. We hypothesize that, among patients presenting to the ED with acute, non-traumatic, low back pain, a single dose of oral CBD will result in lower pain scores on the VAS at 2 hours, with minimal adverse effects, as compared to placebo.

The purpose of this study is to compare the use of fibrin glue with sutures or staples for affixing skin grafts in skin cancer patients. Who is it for? You may be eligible for the trial if you are over the age of 18 and have been diagnosed with any type of skin cancer. If your skin cancer requires a skin graft to close the wound then you may be able to enrol in this trial. If you agree to enrol you would answer some basic questions and be randomised to have either glue or sutures/staples to affix your skin graft. Your surgery and appointments will be the same as if you weren’t enrolled in the trial. After the surgery you would have an appointment at one week and one month where your wound will be reviewed, your pain noted and photographs taken. We hope this research will be able to decrease skin graft failure in patients who have skin grafts for skin cancer.

This is a phase 1 study in healthy subjects. It is planned to develop the drug for reducing pressure in the brain of patients with a traumatic brain injury (TBI). Increased pressure following TBI can lead to death or can cause permanent disability. There are currently no medications that are approved for improving outcomes after TBI. The drug will also be tested for improving clinical outcome in patients that suffered a concussion. The study drug being evaluated is called EU-C-001 and is being developed by an Australian company called PresSura Neuro. Studies in animals have shown that EU-C-001 may reduce pressure in the brain. Therefore, it is thought that EU-C-001 may improve outcomes in patients with TBI by increasing the amount of oxygen available to brain tissue. In other studies it was shown that the EU-C-001 may also have potential to improve outcomes in patients with concussion. This is the first in-man study planned to assess the pharmacodynamic potency as well as safety and tolerability and pharmacokinetics in man after a single intravenous administration when given together with apomorphine. The ability of EU-C-001 to penetrate the human brain is an important prerequisite for efficacy in its core indications. The inhibition of apomorphine-induced emesis will be used in this study as proof of receptor occupancy and EU-C-001 brain penetrance.

Australians are not eating enough vegetables. The CSIRO Healthy Diet Score survey has found that reported to ‘always’ consume 3 different types of vegetables at their evening meal were twice as likely to meet their daily requirements. An explosion of health promoting mobile apps has occurred in recent years including healthy eating ones. However, most mobile apps are not scientifically developed and have yet to undergo rigorous evaluation. Therefore, this research aims to develop and test the useability and effectiveness of a mobile App to increase the variety and amount of vegetables participants consume. Aims / Objectives: The overarching aim is to develop a highly engaging mobile App which motivates adults to increase the variety of vegetables they consume at their main/evening meal to at least 3 different types, as impetus to increase their total variety and the total amount of vegetables they usually consume.

The purpose of the present study is to investigate the impact of potato consumption on postprandial and nocturnal glycemic response and postprandial insulin response when consumed as balanced mixed meal in a real-word setting in individuals with T2DM. Additionally, different cooking methods of potatoes will be explored (baked, boiled and boiled then cooled) and compared to brown rice of equal carbohydrate content (control). We hypothesize ingestion of potato as part of a mixed evening meal will not result in any greater postprandial or nocturnal glycemic response or postprandial insulin response to an isoenergetic, macronutrient-matched control test meal due to the diurnal fluctuations in glucose regulation. Additionally, we hypothesize pre-cooking then cooling potato before consumption will lower the postprandial glycemic response of potato as part of a mixed evening meal.

Young adult onset type 2 diabetes (YT2DM) is an aggressive condition with a rapid progression to diabetes complications. Expert bodies have recommended that YT2DM patients be reviewed every three to six months for assessment of blood glucose control and cardiovascular risk factors. Significant barriers have been identified in the delivery of care for YT2DM patients. The Australian Centre for Behavioural Research in Diabetes has recommended increased support from health care providers and greater engagement in self-care which does not place a significant extra burden on YT2DM patients. A previous survey of our clinic population revealed a high level of mobile phone ownership. Consequently, implementation of an SMS-based intervention to facilitate engagement in the YT2DM cohort would appear to be an ideal strategy to trial. It is hypothesized that by improving engagement in the YT2DM cohort (through a personalised and supportive SMS program), attendance at clinical follow up appointments will improve. This will facilitate an improved approach to diabetes management and the development of a therapeutic relationship between patients and their health care team.

People with severe mental illness are sedentary, have high cardio-metabolic risks and reduced life expectancy. Despite evidence regarding positive physical and mental health outcomes following exercise interventions, evaluation of real-world programs is lacking. The aim was to evaluate the feasibility of an exercise intervention implemented by exercise physiology students within a residential rehabilitation unit for people with severe mental illness. Exercise physiology students implemented a supervised group exercise program for people with severe mental illness. It occurred three times per week, for 10 weeks, on site, at a mental health residential rehabilitation unit, Outcomes were measured pre and post the intervention. Participants in the study were residents of the rehabilitation unit, with a primary diagnosis of schizophrenia. Primary outcomes were the feasibility of the exercise program (recruitment, completion, participation and adverse events). Secondary outcomes included a range of other physical and mental health outcomes assessed pre and post the 10 week exercise intervention.

People meeting the criteria for Borderline Personality Disorder have a variety of mental health and psychosocial difficulties. The disorder can have a significant burden on the person's partner and family and can lead to high costs to health services if left untreated.. Approximately 10% of clients with Borderline Personality Disorder die by suicide. Costs to the health service include a high number of emergency department presentations and hospital beds occupied by people with this condition. Psychological therapy is the mainstay of treatment of borderline personality disorder; However, the demand for psychological treatment has resulted in excessive waitlists for a high risk cohort. This study aims to investigate the effectiveness of a stepped care group program compared to tailored individual care.