Acne vulgaris is a chronic inflammatory condition primarily caused by Cutibacterium acnes, which disrupts skin homeostasis, thereby triggering immune responses and sebum metabolism. Dysbiosis is an imbalance in the skin and gut microbiota identified as a significant factor contributing to acne progression. Standard therapy often relies on antibiotics, but the long-term use has increased antibiotic resistance, including in Indonesia. Consequently, alternative methods, such as probiotics and mesenchymal stromal cell secretomes, are gaining attention for immunomodulatory and regenerative properties. These novel therapies have shown promising results in modulating the skin and gut microbiota while reducing inflammation.

A phase 2 double-blind randomised controlled trial will be conducted using a parallel group design with four arms, namely: (1) standard therapy with oral probiotics and topical secretome (placebo), (2) standard therapy with oral probiotics (placebo) and topical secretome, (3) standard therapy with oral probiotics and topical secretome and (4) standard therapy with oral probiotics (placebo) and topical secretome (placebo). Sixty-four patients with mild to moderate acne vulgaris will be randomly allocated to these groups. Interventions will be administered over a period of 8 weeks, with outcomes to be measured at baseline and post-therapy. This study will be conducted at the Dermatology and Venereology Department of Bali Mandara General Hospital (RSBM). The primary outcome will be the reduction of comedones and inflammatory lesions, assessed using the Yolov8 method. Secondary outcomes will include gut and skin health parameters, such as tryptophan metabolites, collagen, pH, moisture, sebum levels and IL-6, to explore the relationship between microbiome balance, skin condition and inflammation in acne.

This study will be conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and the International Conference on Harmonisation–Good Clinical Practice guidelines. Ethical approval has been granted by the Health Research Ethics Committee of Bali Mandara Regional Hospital (Approval Reference Number: 060/EA/KEPK.RSBM.DINKES/2024). All participants will provide written informed consent prior to enrolment. Data confidentiality and participant safety will be upheld throughout the trial. The results of this study will be disseminated through journals, scientific conferences and relevant academic platforms to ensure wide accessibility and to support further research and clinical application in the field of dermatology, particularly in addressing antibiotic resistance and microbiome-based acne therapies.

NCT06925386.

The Happy Healthy Active Children (HHAC) initiative is a multicomponent community-based initiative aimed at promoting physical activity, food literacy and nature literacy among children in early childhood kindergarten and primary school settings. Developed in collaboration between Activity Experts and Community Stakeholders, HHAC integrates thematic activities (Play, Nature, Food) across kindergartens, schools and the broader community. The initiative responds to growing concerns about declining physical activity levels, insufficient contact with nature and poor dietary habits in childhood, factors known to influence long-term health and well-being. This protocol outlines the design, implementation and planned evaluation of the HHAC initiative.

HHAC is carried out within the long-term strategic initiative Tingbjerg Changing Diabetes. Following the Supersetting approach, HHAC addresses inequity in health by mobilising resources across local settings (kindergartens, schools and the local community arenas) and population groups (children, parents, staff and other community members) to develop and implement contextually relevant activities promoting outdoor play, cooking and nature experiences. Activities are evaluated using a within-subject design in kindergartens, while in schools a quasi-experimental design with matched control groups is applied. Data is collected at baseline and follow-up through accelerometry, validated questionnaires and structured observations. Primary outcomes include physical activity levels, food literacy and nature literacy. Analyses apply linear mixed-effects models to account for repeated measures and clustering at the institutional level. The evaluation also investigates implementation processes and context-mechanism configurations through a comprehensive realist evaluation. This includes developing a programme theory, conducting interviews with children, parents, staff and other local stakeholders and participant observations aiming to explore experiences and the mechanisms through which the activities contribute to changes in behaviour and well-being. All data will be analysed and condensed for a model for transferability.

Findings will be disseminated through peer-reviewed journals, conference presentations and public engagement activities targeting educators, policymakers and health professionals. The intervention materials will also be made freely available to support broader implementation. The study procedures were registered and approved by The Capital Region’s centre for data reviews ‘Videnscenter for Dataanmeldelser’ (Reference: P-2023–14277). All procedures were carried out under relevant regulations and guidelines. Written information about the study was given to all school principals, teachers and parents/guardians before the start of the study, and written informed consent is obtained from all legal guardians of all participants in their native language prior to child enrolment.

To develop prediction models for short-term outcomes following a first acute myocardial infarction (AMI) event (index) or for past AMI events (prevalent) in a national primary care cohort.

Retrospective cohort study using logistic regression models to estimate 1-year and 5-year risks of all-cause mortality and composite cardiovascular outcomes.

Primary care practices in England contributing data to the Clinical Practice Research Datalink (CPRD) Aurum and CPRD GOLD databases between 2006 and 2019.

Patients with an incident (index) or prevalent AMI event. Models were trained on a random 80% sample of CPRD Aurum (n=1018 practices), internally validated on the remaining 20% (n=255) and externally validated using CPRD GOLD (n=248).

Discrimination assessed using sensitivity, specificity and area under the receiver operating characteristic curve (AUC). Calibration assessed using calibration plots.

In the index (prevalent) cohorts, 94 241 (64 789) patients were included in the training and internal validation sets, and 16 832 (7479) in the external validation set. For the index cohort, AUCs for 1-year [5-year] all-cause mortality were 0.802 (95% CI 0.793 to 0.812) [0.847 (0.841 to 0.853)] internally and 0.800 (0.790 to 0.810) [0.841 (0.835 to 0.847)] externally. For the primary composite outcome (stroke, heart failure and all-cause death), AUCs were 0.763 (0.756 to 0.771) [0.824 (0.818 to 0.830)] internally and 0.748 (0.739 to 0.756) [0.808 (0.801 to 0.815)] externally. Discrimination was higher in the prevalent cohort, particularly for 1-year mortality (AUC: 0.896, 95% CI 0.887 to 0.904). Models excluding treatment variables showed slightly lower but comparable performance. Calibration was acceptable across models.

These models can support clinicians in identifying patients at increased risk of short-term adverse outcomes following AMI, whether newly diagnosed or with a prior history. This can inform monitoring strategies and secondary prevention and guide patient counselling on modifiable risk factors.