ANZCTR search results

This open-label, single-centre pilot clinical trial aims to evaluate the effects of daily supplementation with 2'-Fucosyllactose (2'-FL), a human milk oligosaccharide (HMO) prebiotic, in adults with inflammatory bowel disease (Crohn’s disease or ulcerative colitis) and in healthy adults. HMOs are a unique class of bioactive glycans naturally present in human breast milk, with 2'-fucosyllactose (2'-FL) being the most abundant (Thurl et al. 2017; Suligoj et al. 2020; Fanous et al. 2025). All participants will receive 20 grams of 2'-FL once daily for 12 weeks. Stool samples will be collected at baseline, midpoint, end of supplementation, and after a 4-week washout period to assess changes in gut microbiome composition and microbial metabolites. Blood samples will be collected at baseline (week 0), end of the supplementation (week 12), and washout (week 16) to assess systemic inflammatory biomarkers. Gastrointestinal symptoms will be assessed using participant-reported questionnaires at baseline and at the end of the supplementation. Participant adherence and safety will be monitored throughout the study. We hypothesise that daily supplementation with 2'-fucosyllactose will improve gut microbiome composition, reduce inflammation, and alleviate gastrointestinal symptoms in adults with inflammatory bowel disease, with effects that may persist after supplementation. The major questions it aims to answer are: • Can 2’-FL improve symptoms for patients living with moderately active IBD? • Can 2’-FL improve the gut microbiome composition, microbial metabolites, and anti-inflammatory immune markers in IBD patients? • Are the microbiome and anti-inflammatory effects of 2'-FL sustained beyond the supplementation period? • Does 2'-FL produce similar effects on the gut microbiome and immune biomarkers in healthy adults without known bowel disease?

This study aims to investigate whether a cream containing Queen Garnet Plum Extract can help reduce the severity of symptoms in people with mild to moderate atopic dermatitis (eczema). Atopic dermatitis is a common inflammatory skin condition characterised by itching, redness, and dry skin. The study hypothesises that regular topical application of a Queen Garnet Plum Extract-containing cream over 12 weeks may improve skin condition and reduce disease severity compared to a placebo cream without the active extract.

The psychological aspect of sport performance is widely acknowledged but has received less research attention compared to technical, tactical, and physical domains. While mental factors such as psychological skill use and resilience are often attributed to an athletes success, and have a significant contribution to sports performance, their integration within training settings is under-explored. This study aims to determine whether the mental domain can serve as a prescriptive variable in training design. Participants will complete sessions intentionally designed to be mentally challenging, to assess the impact of such training on training quality and examine how athletes use psychological skills to cope the the demands of hard training. This study will also follow a mixed methods design. After completing the training, participants will be invited to take part in a short interview with the lead investigator to further explore their responses to the training intervention.

This study aims to explore how mental fatigue affects cycling performance and body movement in recreational cyclists, and whether these effects differ between cyclists who experience musculoskeletal pain and those who do not. Mental fatigue (caused by long periods of concentration) may make pain feel worse and reduce physical performance, but this has not been tested in cyclists. We hypothesize mentally fatigued cyclists will show lower performance, altered movement patterns, and greater discomfort, with stronger effects in those who already have pain. Understanding this relationship could support better pain-management strategies tailored to mental state. It may also help optimize training, recovery, and rehabilitation for cyclists with pain.

This study will test a brief talking therapy that uses people’s own social memories and images of future social experiences to help adults with depression feel more connected to others. Adults with major depressive disorder and low feelings of social connectedness will complete four weekly one-hour individual sessions with a trained therapist. The therapy focuses on recalling specific times when social connections have felt supportive or meaningful, and on building detailed, positive images of future social situations, with the aim of improving perceived social connectedness and reducing depressive symptoms. The main hypothesis is that, after the intervention, participants will report higher perceived social connectedness, along with improvements in mood, compared with their own baseline levels before therapy.

Our project aims to evaluate a culturally safe cancer care model developed for and by Aboriginal and Torres Strait Islander people in the Cancer Services at South-West Sydney LHD New South Wales. Who is it for? You may be eligible for this study if you are aged 18 years or older and you identify as Aboriginal and/or Torres Strait Islander and you are receiving care through the cancer services at South Western Sydney Local Health District. Families and/or carers of people receiving care at this service will also be able to participate. Study details All participants who choose to enrol in this study will be able to have an Aboriginal Health Worker assigned to their cancer care team. It is anticipated that the Aboriginal Health Worker will be able to provide culturally appropriate support, assist patients with navigating services, and ensuring that care is patient-centred and respectful of cultural values. Healthcare professionals who work in these cancer services will also undergo a comprehensive cultural safety and capabilities training program delivered by a Safe Pathways Aboriginal Educator. It is anticipated that this program will enable healthcare professionals to provide care that is respectful and responsive to the needs of Aboriginal and Torres Strait Islander patients. All participants who choose to engage with these services will also be asked to provide their feedback on the services they used during Yarning sessions with the study team. It is hoped this research will determine whether incorporating Aboriginal Health Workers and a cultural safety and capabilities training program for healthcare professionals leads to better outcomes for Aboriginal and Torres Strait Islander patients and their families who are seeking cancer care. If this initial study finds that either or both of these components are helpful and acceptable to Aboriginal and Torres Strait Islander patients and their families, it is hoped that these services will be embedded in more local health services going forward. By fostering trust and collaboration, this initiative will contribute to reducing the cancer care gap and advancing health equity.

Dry eye disease is a common long-term condition that often occurs when the oil-producing glands in the eyelids become blocked and do not work properly. This study aims to find out whether radiofrequency treatment provides a marked improvement compared the first-line heat-based treatment which is heat masking. We hypothesise that radiofrequency treatment will be more effective than heat masking for patients with varying severities of dry eyes, which justifies the financial investment the machine requires. Participants will receive standard eyelid gland expression following either radiofrequency treatment for heat masking. The results will help inform decisions on deciding between radiofrequency and heat masking for patients with meibomian gland dysfunction.

This study is a prospective, single-arm, single-centre, first-in-human clinical investigation evaluating the safety and feasibility of a new bronchoscopic ultrasound system for the survey and sampling of mediastinal and hilar lymph node stations in patients with confirmed or suspected lung cancer. Who is it for? You may be eligible for this study if you are aged 21 years or older and have a confirmed diagnosis of lung cancer or have been assessed by the Investigator as having a high clinical suspicion and indicated for staging lung cancer. Study details Participants will be sedated and undergo a standard bronchoscopic procedure. Survey of lymph node stations will be conducted using the investigational device, with sampling performed by conventional methods. Follow-up visits will be at 7 days (chart review only). All participants are monitored for adverse events and outcomes related to the procedure and device. It is hoped that findings from this study will help researchers and clinicians determine whether use of this new system is safe and feasible.

This study aims to test whether a nurse-led clinic after hospital discharge is a practical and acceptable way to support people with a stroke and their families/support persons. People with stroke will be randomly assigned to receive either monthly follow-up from a stroke nurse for six months, in addition to usual care, or usual care alone (six-month medical review). The study will examine whether the nurse-led clinic can be delivered as planned, whether patients and families/support persons find it helpful, and whether the nurse can provide care consistently. The study will also explore whether earlier follow-up (one month after hospital discharge) helps to identify and address post-stroke concerns/needs sooner than the usual six-month medical review. Findings will be used to guide future larger studies and inform decisions about wider use of nurse-led stroke clinics in Australian hospitals.

This research aims to trial the intervention My Vital Cycles to improve ovulatory menstrual health literacy, mental wellbeing and selected menstrual health challenges among 13–19-year-old adolescent girls. Teachers and school healthcare professionals from 10-12 schools will be trained to deliver the intervention, which will be trialed with a convenience sample of 420 female adolescents. Expected health outcomes include improvements in mental wellbeing and management of cycle dysfunctions including iron and Vitamin D deficiencies.