ANZCTR search results

The human gut microbiome plays a pivotal role in maintaining gastrointestinal health, immune function, and has been associated with the development and progression of various chronic illnesses. There remains an unmet need for probiotics that provide clinically validated, reproducible, and lasting benefits in broader contexts such as disease prevention and health promotion. In our research, we have developed a bank of isolated microbial strains derived from healthy FMT donors and supported by findings from prior FMT clinical trials conducted by our group and others. These strains have demonstrated consistent clinical and microbiological effects and are being investigated as candidates for a next-generation probiotic formulation. We are examining the impact of administering a combination of these organisms as a probiotic in healthy individuals to assess effects on the gut microbiome.

This study is a pilot and feasibility randomised controlled trial evaluating whether Virtual Reality Exposure Therapy (VRET), when combined with Cognitive Behavioural Therapy (CBT), improves outcomes for individuals experiencing driving anxiety following motor vehicle crashes. A total of 30 participants will be randomly allocated to receive either standard CBT alone or CBT enhanced with immersive VR-based exposure over an eight-week program. The intervention uses personalised, graded exposure scenarios delivered via VR headsets to safely and progressively reduce anxiety related to driving. Outcomes will assess feasibility, safety, acceptability, and preliminary efficacy using validated psychological and quality-of-life measures, alongside qualitative feedback. Findings will inform the design of a future fully powered trial and the potential integration of VR into scalable treatments for driving anxiety.

This study aims to investigate the feasibility of implementing pharmacogenetics in the busulfan dosing method for children undergoing hematopoietic stem-cell transplantation Who is it for? You may be eligible to join this study if you are a male or female paediatric patients aged 0-18 years undergoing Haematopoietic Stem Cell Transplantation (HSCT) with a Busulfan (Bu)-based conditioning regimen. Study details All participants who meet the eligibility criteria in this study will be randomly assigned to one of two groups. The experimental group will receive Bu dosing based on the pharmacogenetics (PG)-based personalised model, the control group will receive dosing according to the traditional McCune model (does not account for genetic factors). The primary outcome measure will be the proportion of first doses that achieve the therapeutic target area under the curve (AUC). Secondary outcomes will include the incidence and severity of treatment-related toxicities, graft failure, relapse rates, overall survival, and event-free survival. An add-on study will investigate the impact Bu metabolites have on Bu clearance and patient outcomes. The study will involve the collection of DNA samples from all enrolled children to determine their GSTA1 haplotypes, which will be used to calculate the personalised Bu doses for the experimental group. It is hoped that this research project will improve the dosing of busulfan in the future with more patients achieving the optimal therapeutic target exposure.

This project will be the first to comprehensively test the hypothesis that oral administration of cannabidiol (CBD) oil modulates brain excitation-inhibition (E-I) using a range of electrophysiological measures (aperiodic activity, gamma band oscillatory activity, mismatch negativity) using electroencephalography (EEG) in neurotypical adults. To that end, we will conduct a randomised, double-blind, placebo-controlled, crossover trial to examine the effect of acute dose 600mg CBD oil on EEG-derived measures of brain E-I.

Study background The WISER Study aims to investigate an educational intervention designed to support sexual health in women with anal cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or older, have been newly diagnosed with anal cancer (any stage), and are planned to receive chemoradiotherapy treatment. Study details All participants will receive a Women’s Initiative for Sexual health, Education and Raising awareness of anal cancer (WISER)-developed educational resource. This resource has been designed to address the sexual health, sexual function, and intimacy information needs of women with anal cancer. The resource will be provided by a healthcare professional (HCP) at the beginning of treatment and revisited during a follow-up consultation before the end of treatment. Feasibility and the impact of the information on patient needs, sexual health, and quality of life will be assessed in participants for up to 6 months after treatment begins. The impact of WISER on HCP awareness and confidence in discussing the sexual health effects of anal cancer treatment will also be evaluated at the end of the study. It is anticipated that this research will contribute to improved supportive care by addressing unmet sexual health information needs and enhancing person-centred care for women with anal cancer.

This study is a randomised, open-label, parallel-group trial evaluating the use of the OmniPod 5™ automated insulin delivery system compared with usual diabetes care in adults with type 2 diabetes undergoing elective hip or knee arthroplasty. The primary aim is to determine whether automated insulin delivery improves peri-operative glycaemic control, measured by percentage of time spent in glucose target range (3.9–10.0 mmol/L) during the two weeks immediately prior to surgery. Sixty-four participants will be randomised 1:1 to automated insulin delivery or usual care, with follow-up extending through hospital admission and post-discharge to 10 weeks. Secondary outcomes include additional glycaemic metrics, peri-operative clinical outcomes, device adherence, psychosocial measures, and health service utilisation. The findings will inform the feasibility, safety, and potential clinical benefits of automated insulin delivery in the peri-operative management of type 2 diabetes.

Brief description of the study purpose The COMPRES study aims to test whether wearing compression gloves and stockings during oxaliplatin chemotherapy is feasible, safe, and may help reduce chemotherapy related nerve damage (peripheral neuropathy) in patients with gastrointestinal cancers. Who is it for? You may be eligible for this study if you are male or female, aged 18 years and older with gastrointestinal cancers who are scheduled to receive oxaliplatin based chemotherapy, are well enough to participate, and are willing to provide informed consent. Study details Those who choose to participate will wear compression gloves (two surgical gloves per hand) and lower limb compression stockings starting 30 minutes before chemotherapy, during the infusion, and for 30 minutes after each oxaliplatin treatment, for a minimum of 12 weeks. This is a non randomised study, meaning all participants will receive the compression intervention during their routine chemotherapy care. Participants will complete questionnaires about nerve symptoms, comfort, and quality of life, and clinical information about side effects and any treatment changes will be collected. No additional blood tests are required beyond standard cancer care. It is help the results from this study will help determine whether a simple, low cost intervention can safely reduce oxaliplatin related peripheral neuropathy and support better quality of life for patients receiving chemotherapy.

The aim is to assess the feasibility and acceptability of delivering Social Rhythm Therapy (SRT) over 12 weeks in an online setting for adults diagnosed with schizophrenia or schizoaffective disorder. SRT is an evidence-based psychological therapy designed to reduce depressive mood and suicidality in people with bipolar disorder, however it has not been tested in people with psychotic disorders (schizophrenia, etc.). Participants will be recruited through social media and through our research group's existing participant pool of individuals with psychotic disorders who have provided consent to be contacted about research opportunities. Primary outcomes are the feasibility and acceptability of SRT delivered online. Secondary outcomes are the intervention’s impacts on social rhythm regularity, mood symptoms, and suicidality.

AIM: The overall aim of the feasibility study is to investigate the effect of a plant-protein and animal-based diet on healthy ageing. OBJECTIVES: 1) The primary objective, in the context of preserving musculoskeletal health as a key component of healthy ageing, is to assess the effect of plant-based and animal-based protein-source diets on muscle fractional synthesis rates in overweight elderly over time. 2) The secondary objectives, aligned with broader determinants of healthy ageing, are to evaluate the difference in plant-based and animal-base protein-source diets on metabolic function (inflammatory markers, glucose variability and lipid profile), cardiovascular outcomes (vascular function and stiffness), feasibility, acceptability and compliance, dietary composition (macronutrients/micronutrients/amino acids/dietary protein quality), and greenhouse gas emissions (life cycle analysis). 3) The exploratory objectives are to evaluate differences in plant-based and animal-based protein-source diets on chemical and activity-based biological ageing markers (proteomic, metabolomic, lipidomic, and physical activity). This study addresses the knowledge gap on the real-life effects of a plant- and animal-protein whole-food diet on muscle protein synthesis and functional health outcomes in elderly and may lay the foundation for more extensive research. The study can guide sample size calculations, methodology, and feasibility of future intervention studies in the same field. The study can help find barriers and refine strategies to reach the target group. Findings may further help guide recommendations for protein intake in the elderly population, and help understanding of the biological mechanisms of the global transition to a more plant-based protein-source diet in the elderly population. Investigation of the exploratory outcomes can help generate hypotheses to inform future research, by providing insight into how molecular pathways affect healthy ageing, thereby supporting the primary aim

This study is pioneering in its investigation of ketamine for the treatment of Post Traumatic Stress Disorder (PTSD). We will do this by reactivating traumatic memory via a short writing task. Ketamine will then be administered following the retrieval of these unpleasant, traumatic memories. When a stored memory is reactivated, it may transition from a consolidated state to a more malleable one, where its content or meaning can be modified. This altered memory is then re-stored through a process called reconsolidation. This mechanism is particularly relevant to PTSD, as theories suggest that the disorder is connected to the processes of fear learning and memory updating. Theoretically, by pharmacologically disrupting this reconsolidation process with ketamine, specific memories can be selectively weakened. This temporary window of memory instability following reactivation provides a novel opportunity to directly alter trauma-related memories and reduce their potential to trigger relapse.