ANZCTR search results

This study will examine the effect of Fibre-fix (dietary fibre supplement) on the human gut microbiome and faecal metabolites of people with Irritable Bowel Syndrome (IBS) who consume a diet low in fermentable oligosaccharide, disaccharides, monosaccharides and polyols (FODMAP). A low FODMAP diet reduces the intake of fermentable fibres, leading to insufficient fermentation by the gut microbiota. This can thereby reduce the production of short chain fatty acids (SCFA, e.g. butyrate) in the large intestine and influence on modulation of sleep and mental health. A randomized double-blind placebo controlled study design is proposed to examine whether Fibre-fix supplement, added to an existing low FODMAP diet may help modulate gastrointestinal function, improve markers of sleep and mental health and promote increased quality of life in IBS patients. Participants will provide stool samples, and complete questionnaires about sleep and mental health before and after the 3-week intervention. Gut health biomarkers: faecal microbiome composition, faecal pH and butyrate levels, and alteration of sleep and mental conditions will be examined. A repeated measures ANOVA using the Statistical Package for the Social Sciences (SPSS) version 25.0 will be used to assess the differences between groups after adjustment for confounding variables. We expect a shift in the diversity of the microbiota and associated increase in the butyrate levels and improvement in general mental health and sleep in those who receive Fibre -fix compared to those who receive control. In addition, the benefits of RS are likely to reduce IBS symptoms and improve gut health whilst on a low FODMAP diet, proposing a long-term dietary solution for those with IBS. The proposed mental health and sleep benefits may have a flow-on effect in terms of lowering the occurrence of other comorbidities, such as depression and work absenteeism which have economic costs, thereby lowering the burden on the healthcare system and reducing healthcare costs for those with IBS.

The primary purpose of this project is to determine whether the use of melatonin improves the quality of sleep in patients undergoing major abdominal surgery. Melatonin is a natural hormone secreted by the pineal gland. Melatonin when given at night works to promote sleep by helping to regulate the body's bio clock and sleep-wake cycles. It is well known that sleep quality in hospital is poor and can cause insufficient sleep which reduces natural immune function. Major abdominal surgery leads to the release of both pro-inflammatory and anti-inflammatory chemical in the blood.. Melatonin could be an effective adjunct medication not only to assist in improving sleep but to dampen the inflammatory response after surgery.

The focus of this project is the treatment of adults with Major Depressive Disorder (MDD) using group psychotherapy. It will examine Cognitive Behaviour Therapy (CBT), an effective type of psychotherapy with outcomes comparable to if not better than medication. In spite of these results, only about 50% of depressed people improve with CBT, and many relapse. Over the years, much effort has gone into exploring ways to improve treatment outcomes for MDD with CBT. Drawing on past and current research, this project combines various components of CBT into a unique and somewhat shorter treatment package. This project aims to answer two key questions: 1. Does this 10 session CBT treatment, delivered in a group format, achieve comparable results with benchmark studies that have primarily used Behavioural Analysis, Cognitive Therapy or CBT treatment over more sessions? 2. Does CBT with the addition of hypnosis (CBTH) achieve better outcomes for MDD than CBT without hypnosis ?

Obesity-related type 2 diabetes (T2D) is increasing in prevalence in Australia and globally, We have shown that there is considerable inter-individual variability in weight loss and glucose benefit in response to a given dose of exercise in adults with obesity, Therefore, the ‘one-size-fits-all’ approach to exercise prescription, which is the basis of current exercise recommendations for obesity-related disease management, is inadequate. This study will employ a ‘Stepped Care’ methodology to meet the need for tailored, individualised strategies for the management of obesity and related conditions. Participants will be randomised into either the Stepped Care arm or a Comparator group (n=80, randomised in 2:1 ratio for Stepped Care: Comparator). All participants in the Stepped Care arm commence on the ‘lowest dose’ prescription, which is incrementally increased based on individual response as defined by predetermined clinical targets. Step 1: = 150 minutes of moderate to vigorous exercise per week; Step 2: = 300 minutes of moderate to vigorous exercise per week; Step 3: = 300 minutes of moderate to vigorous exercise per week including 3 sessions/week of high intensity interval training (HIIT) (4 x 4 min at 85-95% maximal heart rate, interspersed with 3 min recovery bouts at 60-65% maximal heart rate, 3 days/week, with one session/week supervised). The primary AIM of this study is to determine the overall difference between the proportion of individuals with central obesity and type 2 diabetes who achieve the target health outcomes (that is, = 3% weight loss and/or HbA1c = -0.4%) in the Stepped Care and the Comparator groups. The secondary AIMs of this study are to determine the overall difference between the proportion of individuals with central obesity and type 2 diabetes who achieve the target health outcomes in the Stepped Care and the Comparator at i) follow up (6 months), and ii) at each step in the Stepped Care intervention, and iii) determine the magnitude of change in body mass and HbA1c between the Stepped Care and the Comparator groups.

SmartStartAllergy (SSA) is a novel SMS and smartphone-based application currently integrated with general practices to promote and monitor the introduction of allergenic foods. We hypothesise that parents of infants who receive SMS when their child is 6 and 9 months of age, from their general practice that is using SSA, are more likely to feed their child peanut paste before they turn 1 compared with those who do not receive the messages. Parents are randomised to receive automated SMSs from their general practice when their child is 6, 9 and 12 months old, or to only receive SMSs at 12 months (control group). A questionnaire, accessed via link from SMS, collects additional information about infant feeding and food allergy. Proportions of infants who have introduced peanut by 12 months of age, based on responses from parents to an SMS question, will be compared between the two groups.

This study aims to evaluate novel imaging technologies to study breast cancers prior to and following neo-adjuvant chemotherapy. Who is it for? You may be eligible to join this study if you are a woman aged 18 years or above who has previously untreated invasive breast cancer grade 1, 2, or 3. Study details Participants in this study will undergo novel imaging technologies in addition to standard care. This will comprise 3 scans, a MRI, FDG and FES PET/CT scan before starting neo-adjuvant chemotherapy and after the completion of neo-adjuvant chemotherapy. The MRI scans are performed according to routine care, with the participant lying on her stomach with breasts positioned in prone breast coils. The FDG and FLT scans are performed as a whole body scans with the particpant lying on her back, and a prone scan of the breasts. Particiapants need to fast for 4-6 hours prior to the PET/CT scans. Each scan will take approximately 30-45 minutes. These scans will enable us to assess and compare tumours on all imaging studies with pathological samples before and after chemotherapy. These data will provide clinicians with highly accurate functional, volumetric and spatial information. Ultimately, these studies will facilitate individualised treatment strategies, including de-escalation of surgery and radiation therapy.

The aim of this randomised controlled trial is to determine whether the use of a therapeutic dose of lignocaine enhances elective outpatient gastroscopy episodes as measured by time to eye opening, gastroscope insertion conditions, time from patient discharge from recovery and patient comfort (measured by a pain score). Hypothesis: Lignocaine is a local anaesthetic which may assist with improved endoscope insertion conditions, less post gastroscopy discomfort and faster time to wake-up and discharge from the post-anaesthetic recovery unit (PACU).

This study is to assess whether serum tryptases released from degranulating mast cells alone, or in combination with other neuron-specific candidates, can serve as a reliable and rapid biomarker for sports related concussion in children. We hypothesis that a rapid increase in serum tryptases released from degranulating mast cells in the brain, alone or in combination with selected neuron-specific proteins, is a reliable indicator of concussion in young people. This study aims to determine whether biomarkers released following a concussion is an accurate tool for the diagnosis and management of sports related concussions.

Over 1 million patients globally currently manage their Type 1 Diabetes mellitus using continuous subcutaneous insulin infusion with an infusion set that needs to be changed every 3 days. This study will assess the feasibility and device performance of the study device, the Achilles infusion set over three periods during routine insulin infusion. This study will include 20 participants and has 3 periods: Period 1 (up to 7 days): Trial run with study device with saline infusion. Period 2 (up to 7 days): participants will manage their blood glucose solely with their insulin pump and the Achilles infusion set. Blood glucose will be closely monitored with a continuous glucose monitoring (CGM) device. Period 3 (up to 7 days): Participants will return to study centre to receive a fresh Achilles infusion set and continue blood glucose management at home until infusion set failure or 7 days.

Parent-child interactions comprise one of the most profoundly influential experiences in a child’s development, and the quality of these interactions during early infancy in particular can have a lasting impact on neurodevelopment. This randomised controlled trial is a two-arm (Treatment vs Control), single blind (assessor) randomised controlled trial to test the efficacy of a new intervention designed to promote parent sensitivity and responsiveness to their newborns with a family liability for Autism Spectrum Disorder. We hypothesise that the newborn intervention will decrease parental directiveness and increase parental sensitivity during parent-infant interactions when measured when the baby is 9 months of age, and decreases the severity of autistic symptoms, and improve a range of child development outcomes, when measured when the baby is 2 years of age.