ANZCTR search results

The GLOW Trial is a randomised, double-blind, placebo-controlled feasibility trial of enema-delivered faecal microbiome transplant for Long COVID. This trial aims to test the feasibility of a clinical trial protocol of enema-delivered faecal microbiome transplantation (FMT) in adults living with Long COVID.

Eating disorders are highly disabling and have a high mortality rate (Treasure et al., 2020). Clients referred to community mental health services with an eating disorder can wait for 6-12 months to access specialist treatment. Long waitlists have been linked to poorer treatment outcomes, such as increased dropout rates (Carter et al., 2012). The aim is to evaluate the feasibility of using online self-help modules developed by the eating disorders team at the Centre for Clinical Interventions (CCI) to support people with eating disorders who are currently not receiving treatment. CCI provides free online evidence-informed self-help modules for eating disorders – Break Free from ED (BFED) - which have been accessed over 350,000 times since July 2022. The present research study will evaluate the feasibility of using the BFED modules in a self-help format with minimal guidance in reducing eating disorder and related symptoms.

PrEP STAT is an open-label-two-arm RCT designed to evaluate the uptake of PrEP where Medicare-ineligible MSM receive the intervention—the free PrEP STAT pack (Tenofovir disoproxil fumarate 300 mg and Emtricitabine 200 mg)— compared to those who receive the control —a prescription for PrEP with a PrEP initiation infosheet. Clients will receive either the intervention or control within their consultation at MSHC. This trial will be carried out between June and September 2025. The trial will be integrated into routine care, in which clinicians will be digitally notified (via a message on the client file) when eligible clients visit the centre. Participating clinicians will assess eligibility and invite eligible clients to participate in the PrEP STAT trial.

The Kids Connect Integrated Program aims to increase the engagement of parents and families with the health services by optimising the uptake of child developmental checks through the WMG-E platform. Secondly, this program will include screeners for parental mental health and unmet family psychosocial needs. Intervention in this study is tiered care and support provided to families based on the survey responses. While both both groups receive universal resources (Tier 1), intervention group will receive targeted support for tiers 2, 3 and 4. Tier 2 will include general information of local support services via automated REDCap email. Tier 3 will include digital contact with Service navigator and recommendations of targeted support services, follow-up with email/SMS check-in in the next month. Tier 4 will include direct contact with service navigator over phone, with assistance to access services (warm hand-over), with regular follow-up calls over the next few months, as appropriate. Outcomes include the uptake of child developmental checks, utilisation of resources and services for child development, parental mental health, breastfeeding practices, and family psychosocial needs. We hypothesise that the provision of extra resources and service navigator support will increase the uptake of developmental checks and mental health screeners, will increase the utilisation of health services and improve outcomes of parental mental health, breastfeeding practices and family psychosocial needs.

This study aims to assess the diagnostic and predictive powers of host/bacteria-derived EVs, Ti ions, and inflammatory cytokines in saliva and PICF across peri-implant health, peri-mucositis, and peri-implantitis patients following nonsurgical treatments at 0, 3, 6, and 12 months. This study has two main aims: Aim 1: Assess the diagnostic power of host/bacteria EVs, Ti ions, and cytokine profiles as biomarkers in saliva and PICF to diagnose peri-implant health, peri-mucositis, and peri-implantitis patients. Aim 2: Assess the predictive power of host/microbial EVs, Ti ions, and cytokines as biomarkers in saliva and PICF for monitoring the treatment response of peri-implantitis patients following non-surgical treatment for up to 12 months.

This study is testing two new products to diagnose and treat patients with advanced solid tumours. One product (called 68Ga-3BP-3940) helps to see the tumours using a PET/CT scan, and the other (called 177Lu-FO-004) is used for treatment. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with an advanced/metastatic solid tumour. Study details: All participants will undergo a PET/CT scan at the beginning of this study using 68Ga-3BP-3940 as a tracer. Once this has been completed satisfactorily participants will take part in one of two parts in this study: - Part 1 (Dose Escalation): Up to 30 patients will be divided into 4 groups. Each group will receive up to 6 doses of 177Lu-FO-004 treatment every 6 weeks to find the best dose for the next phase. - Part 2 (Dose Expansion): Up to 26 patients will receive the optimal dose of 177Lu-FO-004 found in Part 1 to confirm its safety and effectiveness. Some of these patients will have extra tests to check how the drug moves through the body and its effect on the heart. All participants in this study will have SPECT/CT scans at 4 times in Cycle 1 and two scans for each additional cycle. All participants will also have CT scans every 12 weeks for up to 2 years to monitor the disease. Participants will also be followed up throughout the study to assess side effects. It is hoped that this study will determine how safe and tolerable 177Lu-FO-004 is for patients with advanced solid tumours and to find the best dose to use.

The Endobronchial VAlves for Pneumothorax On Reducing Admission Time (EVAPORATe) study is a pilot feasibility multi-centre randomized controlled trial (RCT) to investigate if an early referral of patients with PAL from SSP for EBV can help shorten total length of hospital stay. The pilot data will inform in protocol feasibility and power calculation for the next stage (full-scale) RCT

This study seeks to establish a safe, one-step oral provocation challenge pathway for children with penicillin allergies. To be eligible, children must have experienced a low-risk initial reaction, such as a mild rash or a delayed urticarial rash. The goal of this approach is to inform primary shared care pathways for conducting penicillin testing in children within the community.

This study will conduct a hybrid type II implementation trial of a co-designed school and community support program to address food insecurity among Aboriginal families. Utilising culturally appropriate mixed methods and community-based participatory research approaches, the study will: • adapt and tailor a pilot program for relevance in other communities; • test the effectiveness of the program in shifting food insecurity among Aboriginal families (primary outcome) and in enhancing food and nutrition literacy (secondary outcomes); and • determine the barriers and enablers for scale up at other sites.

Exclusive enteral nutrition (EEN) is a dietary therapy for the treatment of Crohn's disease (CD) well established in reducing inflammation, particularly in paediatric CD. Gaps in knowledge relating to EEN remain, particularly relating to mechanism of action, impact on body composition, quality of life and adherence, particularly in adult cohorts. This study aims to address many of these gaps in knowledge through prospectively evaluating adult patients commenced on EEN, including objective measures of disease activity (biochemical, sonographic), body composition measures, novel biomarkers, adherence and quality of life over 6 weeks. It is hypothesised that EEN will lead to sonographic response, improvements in body composition and muscle strength as well as clinical symptoms and quality of life