ANZCTR search results

On average, only 50% of IBS patients respond to the first-line treatment of low FODMAP diet. The non-responders may have gut microbiome dysbiosis that requires targeted treatment. Recent RCTs have shown improvement in IBS symptoms using faecal microbiota transplantation (FMT) from healthy donors in IBS symptom scores up to 3 months, with the proposed mechanism being the correction of gut dysbiosis, However, there is a lack of studies into the impact of FMT in combined with low FODMAP therapy to optimise the improvement of IBS symptoms. This study aims to investigate whether the novel therapy of FMT improves IBS symptoms for IBS patients without significant symptom improvement after a low FODMAP diet. Methods: IBS patients with moderate to severe symptoms will be enrolled into a dietician-led 3 week low FODMAP treatment. The patients who do not have symptomatic improvement will be randomised into receiving FMT or placebo. Studies suggest that altering microbial composition via FMT might also lead to improvements in cognitive function. Therefore, we will investigate cognitive function at baseline compared to follow-up in a subsample of 20 enrolled participants. In contrast to participants of the overarching clinical trial, sub study participants will undergo additional cognitive testing, which takes around 50 minutes per visit, and will be asked to fill out additional mood and quality of life questionnaires, which will add another 10 minutes to study visits. This result in a total study visit time of 80 minutes for substudy participants, as opposed to 20 minutes for participants of the overarching trial, who will only fill out two questionnaires on IBS-symptom severity. Cognitive function will be assessed via Cambridge Automated Neuropsychological Test Battery (CANTAB), a validated, computer-based, neuropsychological test battery that allows testing for cognitive changes in different cognitive domains, including memory, processing speed, and executive function. To assess the impact of mood and stress on IBS symptom severity, mood will be assess via the Depression, Anxiety and Stress Scale (DASS) and quality of life via IBS-QoL.

Extensive research has demonstrated that yoga is beneficial for general physical and mental health and well-being. However, only limited yoga-based interventions have been developed specifically for children living with Autism, with mixed results in reducing psychological distress and enhancing wellbeing. This study aims to understand the effects of a novel yoga intervention for reducing anxiety in children (aged 6 to 18) with Autism. This intervention is developed and co-designed with considerations of the special needs of children living with Autism, and it is primarily focusing on yoga postures, mindfulness awareness, breathing and relaxation training. The classes will run online, 1 hour per week for 8 weeks in a group setting.

Several studies have shown that the efficacy of non-invasive brain stimulation techniques such as tDCS and tRNS on cognitive function is partially modulated by individual characteristics. One of these characteristics is the amount of the neurotransmitter dopamine (DA) that a person has. Because some of the DA that is available in the human body is derived from our diet, one way of estimating DA availability is by using a food questionnaire which can tell us about someone’s tyrosine intake. Tyrosine is an amino acid that can be found in a variety of foods, and that through a chain of metabolizing steps eventually gets converted to DA. Thus, we hope to able to predict the effectiveness of tDCS/tRNS on planning and memory performance by an individual dietary consumption of tyrosine

An eHealth solution – Music Attuned Technology for Care via eHealth (MATCH) – was developed to support family carers of people living with dementia to use music intentionally to support care. To create scalable solutions for the growing number of people living with dementia, we developed a minimal viable product (the MATCH app) for the HOME setting, which will be adapted for the RAC setting in study 3. MATCH represents a paradigm shift in music and dementia technology because it will: a) embed training programs that guide FCs and professional care staff in the strategic use of music; b) use sensor technology to capture behavioural markers to interpret agitation levels and auto-suggest music using algorithms that learn preferences of the person living with dementia and then suggest music they may like (recommender system); c) be able to continuously adapt the music to match and attune to arousal levels and reduce agitation; and d) be accessible to culturally and linguistically diverse groups (training videos will be available in multiple languages). Stage 2 of this study aims to explore digital markers, using wearable sensor devices, as best indicators of agitation and other symptoms to inform the development of an AI system that can detect changes in agitation in response to music and refine music recommendations to reduce agitation symptoms in residents living with dementia. We expect that data from the sensor devices will be able to support the detection and better management of agitation symptoms in people living with dementia.

The purpose of the study is to assess a new type of closure for deep burn injury. It will evaluate the safety and efficacy of bioengineered human skin equivalent (HSE) for the closure of full thickness wounds in burn patients requiring excision and skin grafting, and will compare the outcomes with areas treated with standard split skin grafting. HSE is skin which is constructed in a laboratory, using skin cells, which have been extracted from a participant’s skin sample. This project involves using and comparing two variations of the HSE, as well as using standard burns treatment, and assessing the outcomes. The participant may receive one or both variations of the HSE, and will also receive split skin grafting to some of their burns. The three different possible treatments for the participant's burn wounds are: • HSE using platelet hydrogel, which is made with platelets supplied by Australian Red Cross Lifeblood. Platelets are a component of blood, which are involved in the clotting process. These are combined with a hydrogel, which is a water soluble sheet used to grow the skin cells. • HSE using Novosorb® polyurethane polymer, which is a biodegradable foam, widely used in the treatment of burns. • The remaining burn areas will be treated with split skin grafts. The participant will have skin grafts applied to some of their burn injuries. The treated areas are subsequently assessed and photographed at 7-10 days post HSE application, 4 weeks post HSE application, 6 months post HSE application, and 12 months post HSE application.

Negative symptoms are frequently experienced by people with schizophrenia. People with negative symptoms often have impaired social functioning and reduced quality of life. There is some evidence that Cognitive Behavioural Therapy (CBT) results in a modest reduction in negative symptoms. It is unclear if similar effects can be achieved using Behavioural Activation (BA). This study will examine the feasibility and acceptability of implementing a BA tele-trial delivered collaboratively with three rural mental health services (Flinders and Upper North Local Health Network, Riverland and Coorong Local Health Network, and Limestone Coast Local Health network) that provide mental health services for people with Serious Mental Illness. Methods We aim to recruit 60 consumers aged 18 years or above with negative symptoms of schizophrenia as indicated by mild to moderate negative symptoms [greater than 3 on at least two negative symptom items from the Positive and Negative Syndrome Scale (PANSS). In addition, we aim to recruit eight mental health workers from three rural mental health services in South Australia and prepare them to deliver BA to consumers of their service. Consumers will be randomised to receive BA plus usual mental health care service or usual mental health care service alone. The BA plus usual mental health care service component will involve 12 sessions of up to one hour in duration which will be delivered over 12 weeks. Our team of experts will support the mental health workers to deliver BA via telehealth supervision and structure. This also helps to ensure fidelity to the intervention. Specific BA techniques that will be applied include the identification of depressed behaviours; analysis of the triggers and consequences of depressed behaviours; monitoring of activities; development of alternative goal-orientated behaviours; scheduling of activities; and the development of alternative behavioural responses to rumination. Changes in negative symptoms of schizophrenia (primary outcome) and depression (secondary outcome) will be assessed at three-time points: (a) at baseline, at 6 weeks, and 3-month follow-ups. Changes in health-related quality of life (secondary outcome) will be assessed at two-time points: (a) at baseline and (b) immediately at postintervention after six weeks. We will use the PHQ 9 and the SF36 scales to assess changes in mood and health-related quality of life, respectively. Descriptive statistics and thematic analysis will be used to assess feasibility and acceptability.

.It is now widely accepted that respiratory viruses are transmitted via aerosols. This study will use air purifiers with HEPA filters in the rooms of residents of RACFs. It intends to examine the effect of air purification through filtration on the incidence of acute respiratory infections in RACFs. It will help to identify whether air purifiers could be used to decrease the burden of acute respiratory infections in residential aged care settings.

People in custody are at high risk of developing depression. Accessing psychological treatments such as Cognitive Behavioural Therapy (CBT) in a prison setting is a particular challenge in part due to difficulties in accessing specialist mental health workers. An alternative treatment, Behavioural Activation (BA), is just as effective as CBT for depression in adults who are not in prison settings. The application of Behavioural Activation may increase access to an effective treatment for people in custody with depression. However, we lack trial data concerning its acceptability and feasibility. This study will establish the feasibility and acceptability of preparing custodial health nurses to deliver BA to improve depression symptoms in people in custody. Findings from the study may provide opportunities for scaling up BA to support people in custody living with depression.

This project aims to assess the feasibility, safety, and potential efficacy of oral cannabis oil in relieving pain and other symptoms in people with fibromyalgia syndrome (FMS). Thirty-six patients (n=36, allowing 20% attrition) diagnosed with FMS will be recruited to take part in a 16-week double-blind, randomised, placebo-controlled trial. Eighteen patients will be given a product containing cannabis oil; the other 18 participants will receive a placebo oil similar in look, taste, and smell. Due to intra-variability of participants metabolism and response to cannabis, an initial slow increase of dose will occur for the first 4 weeks to establish the tolerated dose for that participant. They will then take that dose for another 12 weeks to examine its effects on pain and other symptoms associated with FMS such as sleep, mood, and quality of life.

This study looks at the use of the nasogastric tube in the management of small bowel obstruction in patients with a history of abdominal surgery. The null hypothesis is that not using the nasogatric tube results in an more operations than the nasogastric tube. Small bowel obstruction is a surgical emergency and at its worst can result in the death of a patient due to small bowel infarction. The accepted standard of care is insertion of a nasogastric tube to decompress a distended stomach. There is little if any research evidence to support this practice and this study seeks to compare this practice to not using a nasogastric tube and observe if it results in less patients having srugery to the condition.