Clostridioides difficile infection (CDI) is a leading cause of healthcare-associated diarrhoea in adults, with recurrence rates of 15%–25% after a first episode and up to 65% after multiple recurrences. Recurrent CDI leads to significant morbidity, diminished quality of life, prolonged antimicrobial exposure and increased healthcare utilisation. Faecal microbiota transplantation (FMT) demonstrates high efficacy for multiple recurrent CDI, but its benefit when used earlier—after the first episode in high-risk patients or first recurrence—remains insufficiently studied. Emerging evidence suggests early FMT may improve sustained clinical cure rates and reduce recurrence. This trial evaluates whether early introduction of oral FMT following standard therapy improves outcomes compared with standard therapy alone.

This is a multicentre, randomised, open-label, pragmatic phase III superiority clinical trial conducted across eight Swiss clinical centres. A total of 100 adults will be enrolled. Patients with either (1) a first CDI episode and risk factors for recurrence or (2) a first CDI recurrence and who first receive the real-world standard of care anti-CDI antibiotics (10 days of vancomycin or fidaxomicin) are randomised 1:1 to oral FMT following standard antibiotic therapy or standard therapy alone. The intervention group receives within 12 hours to 4 days of the last antibiotics administration, 15 to 20 oral FMT capsules twice on two consecutive days if the CDI is non-severe; those with severe CDI receive an additional 2-day FMT course. The control group does not receive any additional treatment after completing the 10 days of standard therapy. The primary endpoint is the proportion of patients having experienced a CDI recurrence at 8 weeks post completion of treatment (assessed per-protocol and intention-to-treat). Secondary outcomes include early and late recurrence rates, sustained cure at 6 and 12 months, quality-adjusted life years, recurrence-free and overall survival at 12 months. Exploratory analyses include microbiota diversity, biomarker identification and assessment of immunologic and microbial predictors of recurrence. Safety/tolerability is also assessed.

The study will be conducted in accordance with International Council for Harmonisation Good Clinical Practice, the Declaration of Helsinki and Swiss regulatory standards. Results will be disseminated through peer-reviewed publications and conference presentations.

NCT05266807.

Primary liver cancers, including hepatocellular carcinoma and intrahepatic cholangiocarcinoma, are one of the leading causes of cancer-related mortality. Transarterial chemoembolisation (TACE) and radioembolisation (TARE) are established palliative treatments yet they are traditionally performed during inpatient hospitalisation. Recent technical and organisational advances allow for safe same-day ambulatory procedures. In particular, the extent to which ambulatory intra-arterial therapy aligns with patients’ expectations, comfort and quality of life remains poorly documented. The Care pathway for Hepatic intra-arterial Oncology in an ambulatory Context study (CHOC) trial aims to evaluate the implementation and effectiveness from both patient-centred and clinical perspectives of an ambulatory care pathway for intra-arterial treatment of primary liver cancer in a multicentre randomised hybrid type 1 trial.

CHOC is a pragmatic, multicentre, randomised controlled hybrid type 1 trial comparing ambulatory versus conventional inpatient care for patients undergoing TACE or TARE for primary liver cancer. A total of 206 patients (103 per arm) will be randomised 1:1 and followed for 7 months. The primary outcome is the patient’s global satisfaction score, measured 3 days post-procedure using the EORTC PATSAT-C33 questionnaire. Secondary outcomes include quality of life, safety, clinical outcomes, cost analysis and an embedded qualitative implementation study assessing acceptability, adoption, feasibility and sustainability across centres. Economic analyses will estimate both per-patient costs and the 5-year budget impact for the French national health insurance.

The study has received ethical approval from the Protection of Persons Committee and adheres to the Declaration of Helsinki, good clinical practice and French regulatory requirements. Findings will be disseminated through peer-reviewed publications, conferences and participating centres to guide broader implementation of ambulatory interventional radiology care.

NCT06990659.