Allergic rhinoconjunctivitis (ARC) is a highly prevalent immune-mediated condition associated with substantial symptom burden, impaired quality of life and increased healthcare use. Emerging evidence highlights the role of the gut microbiome in immune regulation and allergic disease. Fermented foods may contain live microbes (when unpasteurised or uncooked) and bioactive postbiotic metabolites that can modulate immune responses. Despite growing interest in dietary strategies targeting the microbiome, no randomised controlled trial has compared fermented versus unfermented red cabbage for ARC.
This single-centre, randomised, controlled trial with a sensory-matched, unfermented cabbage comparator investigates the effects of daily consumption of fermented red cabbage for 8 weeks compared with an unfermented red cabbage control in young adults (18–35 years) with ARC. A total of 158 participants will be randomly assigned (1:1). The primary outcome is change in Total Nose and Eye Symptom Score from baseline to week 8. Secondary outcomes include daily symptoms and medication use captured via mobile ecological momentary assessments, quality of life, psychological well-being, gastrointestinal symptoms, systemic inflammatory markers, total IgE, immune cell profile and metagenomic characterisation of stool samples. A nested qualitative component explores participants’ experiences and acceptability of the intervention. Analyses will include mixed-effects models, time-series analyses incorporating daily pollen counts and comprehensive microbiome statistics. Safety outcomes and adverse events will also be assessed.
This study was approved by the Ethics Committee of Charité—Universitätsmedizin Berlin (EA4/043/25) and is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Results will be disseminated through peer-reviewed publications, conference presentations and a lay summary provided to participants. Anonymised datasets and analysis scripts will be made available in public repositories, and metagenomic sequencing data will be deposited in an international sequence archive to ensure transparency and reproducibility.
DRKS00036475.
Kerato-lenticule extraction (KLEx) is a refractive surgery technique that, in contrast with femtosecond laser-assisted in situ keratomileusis (FS-LASIK), does not require the creation of a flap to correct refractive defects. The potential advantages of this technique are related to the absence of a flap and its complications. On the other hand, FS-LASIK is the most widely practised refractive surgery worldwide, as it offers excellent visual outcomes and is currently the gold standard of refractive surgery. The objective of this study is to compare the effectiveness and safety of KLEx versus FS-LASIK as a treatment option in patients with myopia or myopic astigmatism.
This double-masked, parallel-group, single-centre randomised clinical trial will enrol 80 eyes from adults with myopia or compound myopic astigmatism within the ranges sphere –0.50 to –12.00 D and cylinder –0.50 to –6.00 D, recruited at the Instituto de Oftalmología Conde de Valenciana, Mexico City, Mexico. Participants will be allocated to KLEx or FS-LASIK and assessed at baseline and 1 day, 1 week, 1, 3, 6 and 12 months postoperatively. The primary outcome is uncorrected visual acuity at all postoperative visits. Secondary outcomes include postoperative spherical equivalent, best-corrected visual acuity (BCVA), loss of ≥2 BCVA lines, the proportion of eyes within ±0.50 D of the refractive target, corneal aberrations over a 5 mm pupil, epithelial changes and adverse events. Participants and outcome assessors will be masked to the assigned surgical technique.
Participant confidentiality will be maintained with the publication of results. This study was approved by the research and ethics committee of the Instituto de Oftalmología Fundación de Asistencia Privada Conde Valenciana (CI-017-2024). The study results will be disseminated in scientific articles published in peer-reviewed journals and presented through research posters at national and international conferences.
ClinicalTrials.gov registry (NCT06477081).
Depressive symptoms are common in the growing geriatric surgical population and are associated with important patient-centred surgical outcomes, including postoperative delirium, discharge to postacute care facility and decline in functional status. Few interventions have been developed to address depressive symptoms in the perioperative setting.
We designed a feasibility and acceptability study of a nine-session problem-solving therapy (PST) telehealth perioperative intervention aimed at reducing postoperative functional decline and depressive symptoms among at-risk older adults undergoing major surgical procedures. Acceptability will be evaluated using a patient-centred five-question survey, assessing participant satisfaction and perceived usefulness of the perioperative intervention. A feasibility assessment will rely on objective measures including ease of participant recruitment, frequency and timing of delivery of intervention sessions and retention of participants throughout the duration of the intervention. With respect to the efficacy of the proposed PST intervention, the primary outcome of interest is postoperative functional status, as measured by the WHO Disability Assessment Schedule 2.0 at the 6-month postoperative time point. The secondary outcome of interest is the degree of depressive symptoms as assessed by the Patient Health Questionnaire-9 at both 3 months and 6 months postoperatively. The broader goals of this study include: (1) assessing the feasibility of implementing a PST perioperative intervention for older surgical patients at risk of postoperative functional decline, (2) demonstrating the acceptability of the PST intervention and (3) assessing the preliminary impact of the PST intervention on postoperative functional status and depressive symptoms.
The study received ethical approval from the University of California San Francisco Institutional Review Board. Results of this study will be published in peer-reviewed scientific journals with further dissemination at local institutional meetings and professional conferences.