ANZCTR search results

Accidental falls are a costly public health problem and can result in significant negative implications for the individual, particularly when resulting in injury and hospitalisation. A range of factors are known to influence one’s risk of accidental falls, including age, physical activity, quality of life, fear of falling and social interaction/isolation. In an era of rapid changes in the way we socially interact and/or isolate, this may have important implications for falls risk. Thus, the aim of this observational study is to examine the predictive effect of social interaction, physical activity levels, quality of life and fear of falling on falls incidence in older adults.

Iron deficiency (ID) is the most common worldwide nutrient deficiency, is of particular concern to athletes due to the fundamental role of iron in optimal sports performance. Exercise-induced physiologic changes may be a possible explanation for the high rates of ID in athletic cohorts. These mechanisms include iron losses via sweat, gastrointestinal bleeding, hematuria, and repeated inflammatory mediated increases in the iron regulatory hormone hepcidin. Furthermore, in female athletes, the iron losses associated with menstruation add an extra burden that may contribute to the high rates of ID seen in female compared to male athletes (~35% vs ~10%, respectively). Although these mechanisms have been examined in isolation, whether the sustained and combined effects seen in high performance athletes have a meaningful impact on iron metabolism and long-term iron balance is unknown. Therefore, the primary aim of this study is to compare iron absorption, loss and overall balance using iron isotope tracers in endurance trained athletes with recreationally active individuals at regular intervals across a 12-month training cycle. 12 months after the iron isotope tracer is administered, participants will attend the laboratory at 3 monthly intervals for a 12 month period (5 visits). Participants will have a venous blood sample collected and measured for markers of iron status and isotopic the isotopic iron composition, as well as an assessment of hemoglobin mass. Information around habitual dietary intake (specifically iron), menstrual cycle history and training volume will also be collected at each visit. Outcomes of this study will increase our understanding of iron requirements for athletes against those of the general population.

This study will collect endometrial biopsies from women who are having laparoscopic surgery. During their operation, the presence +/- severity of a condition called 'endometriosis' will be graded. We hope to see whether or not there is a correlation between 'BCL6' levels on their endometrial biopsy specimen, with the presence +/- severity of endometriosis at keyhole surgery.

A key barrier to hepatitis C (HCV) diagnosis and treatment is the multi-stage process of conventional HCV testing as patients require multiple visits to pathology services and healthcare providers to obtain a HCV antibody test, then a HCV RNA test, receive the result and finally be linked into care. This novel study aims to scale up HCV screening in the community by providing HCV point-of-care (POC) testing, liver assessment and direct referral into treatment at the priority settings of mental health, prisons and alcohol & other drugs (AOD) services. The study will investigate the benefit of providing POC HCV diagnostic testing using SD Bioline fingerstick antibody (Ab) assay and Cepheid fingerstick HCV RNA for participants who return a positive HCV Ab result. Providing same day test results and referral for treatment in one visit addresses a major barrier to HCV treatment uptake, particularly in people at high risk of HCV infection such as people who inject drugs (PWIDs).

Reduced cardiorespiratory fitness is a common secondary impairment for people who have sustained a severe traumatic brain injury (TBI). Gamification including virtual reality (VR) may be one strategy to provide a motivating environment for fitness training. A recent large randomised controlled trial (n=300; including 18 adults with severe TBI) conducted by members of the research team, provided additional rehabilitation using digital devices and demonstrated improvements in mobility and self-reported physical activity at 6-months and cognition at 3 weeks. Fitness training and virtual reality has been investigated in people after TBI by one single group study conducted over 20 years ago. In this study, 13 people with severe TBI underwent 4 weeks of fitness training on a cycle ergometer using VR. This study showed promising results in cognitive changes, but no follow up work was conducted. Given the improved knowledge in dosage and benefits of fitness training in this population, and the growing interest and access to virtual reality systems, a pilot study focused on how best to implement this type of program in practice is warranted. This study will evaluate the efficacy of gamification on outcomes from fitness training using a single-case experimental design protocol with a group of patients from the Liverpool Brain Injury Rehabilitation Unit who require physical rehabilitation after TBI.

Oesophageal soft food bolus obstruction (SFBO) is a common gastroenterological presentation. Mentha piperita, the active component of peppermint oil has been proposed as an adjunct in SFBO. This study is to evaluate the effectiveness of Mentha Piperita in facilitating spontaneous passage of SFBO and improving effectiveness of the endoscopic push technique, via a prospective randomised control trial. To check effectiveness of peppermint oil in relieving blockage from food stuck in the food pipe.

The primary aim of the trial is to investigate if a combination of HMOs and probiotics can improve behavioural outcomes for children with autism spectrum disorder (ASD). This aim will be tested in a two-phase clinical trial. Phase 1A is an 8-week randomised, double-blinded, placebo-controlled trial. Participants will be recruited and randomised (1:1) to receive either the investigational product (treatment group, n=30) or the placebo (control group, n=30). Phase 1B is an 8-week open-label study. All participants that complete Phase 1A will move into Phase 1B (n=60). This allows all participants to receive the investigational product and will provide additional information on increased duration of treatment. The primary outcome will be measured by the irritability subscale of the Aberrant Behaviour Checklist (I-ABC), Other behavioural measurement tools to support the primary end-point include behavioural changes as measured by the Home Situational Questionnaire – ASD (HSQ-ASD) and the Parent-Targeted Symptom Visual Analogue Scale (PTSVAS), Secondary measures include change in: gastrointestinal symptom severity; stool consistency, quality of life; anxiety; gut (stool) microbial composition; stool short chain fatty acids levels; urinary serotonin concentration; and saliva cortisol levels. It is hypothesised that a combined supplement of HMOs and probiotics will improve behavioural outcomes for children with ASD via mechanisms of the microbiome-gut-brain axis. Evidence of efficacy will support additional research to investigate the gut micorbiome as a therapeutic target for this cohort.

Clinical Islet Transplantation at our center, akin to others internationally, achieves insulin independence rates of ~80% at 1 year in hypoglycemic unaware type 1 diabetics with poorly controlled disease. A major problem with current islet cell transplantation is the delivery of the islets into the portal circulation (via infusion into the liver). Up to 75% of the transplanted islet mass is lost within the first 24 hours due to low oxygen levels in the portal circulation and the instant blood mediated inflammatory reaction (IBMIR). Thus one of the major aims for the field of islet transplantation has been to develop a vascularised alternative site for islet transplantation that avoids the portal circulation. The aim of this application is to change the current paradigm of beta cell replacement with intra-portal islet transplantation, by establishing a clinical protocol to place adult islets in a pre-vascularized “intracutaneous” space. The intracutaneous space represents an attractive site for islet transplantation (ease of access, administration, monitoring, removal or replacement), however, it has been attempted unsuccessfully by groups in the past. The reason for failure of the ‘normal’ intracutaneous site is that the collagen structure produces a low oxygen (hypoxic) environment incapable of supporting islet survival and function. The BTM integrated into the intracutaneous site is much different! Implanting BTM into the intracutaneous site prior to islet transplant enables the formation of a dense vascular bed which is essential for islet survival and function. It is hypothesised that the proposed pilot study will demonstrate that the techniques described result in the successful intracutaneous seeding of human islets capable of secreting insulin to control blood glucose levels.

The study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single (Part A) and multiple (Part B) doses of RLYB116 in healthy participants.

Diet has potential to bridge the therapeutic gap in ulcerative colitis (UC). The proposed study evaluates a therapeutic diet for patients with mild-moderately UC. This diet will be tested in an 8-week randomised, placebo-controlled dietary advice study. Patients with mild-moderately active UC on stable therapy will be eligible for inclusion. Those eligible will be invited to provide informed consent then undertake baseline measurements including a 48-h stool collection, blood and urine sampling, clinical questionnaires, 7-day weighed food diary and a flexible sigmoidoscopy to confirm presence of inflammation. Participants will then be enrolled and undergo ingestion of a gas-sensing capsule before being randomised and blinded to receive one of two diets from a research dietitian. Meal plans and recipes will be provided along with a selection of food items. Participants will be reviewed at weeks 4 and 8, with repeating of baseline assessments at week 8.