Clinical Report: Design of the LEONORA Randomized Clinical Trial

Overview

The LEONORA trial aims to evaluate the impact of synbiotic prophylaxis on lower gastrointestinal symptoms following colorectal cancer surgery. With a sample size of 206 patients, it is set to be the largest placebo-controlled trial of its kind, focusing on postoperative complications and microbiota changes.

Background

Colorectal cancer surgery often leads to persistent gastrointestinal symptoms, affecting patients' quality of life long after treatment. Synbiotics, which combine probiotics and prebiotics, may offer therapeutic benefits by improving gut microbiota and reducing postoperative complications. This trial is significant as it addresses a gap in current research regarding the long-term effects of synbiotics in colorectal cancer patients.

Data Highlights

No numerical data available in the source material.

Key Findings

• The LEONORA trial will utilize a more diverse probiotic formulation compared to previous studies.
• It will administer a more potent prebiotic and extend the therapy duration from 15 to 90 days.
• The trial will be conducted in a multi-center setting within Germany, enhancing its generalizability.
• With 206 participants, it will be the largest placebo-controlled RCT on synbiotics in CRC patients.
• The study will investigate the effects of synbiotics on the emergence of multidrug-resistant organisms.

Clinical Implications

The findings from the LEONORA trial could inform clinical practices regarding the use of synbiotics in colorectal cancer surgery, potentially improving patient outcomes and reducing postoperative complications. Understanding the role of gut microbiota in recovery may lead to enhanced therapeutic strategies.

Conclusion

The LEONORA trial represents a critical advancement in understanding the role of synbiotics in postoperative care for colorectal cancer patients. Its outcomes may significantly influence future guidelines and practices in this area.

References

1. Theodoropoulos et al., 2023 -- Efficacy of Synbiotics in CRC Patients
2. ERAS® Society, 2025 -- Guidelines for Preoperative Care in Elective Colorectal Surgery
3. Do Perioperative Probiotics/Synbiotics Reduce Postoperative Infection Rates Following Elective Colorectal Surgery? A Systematic Review and Meta-Analysis, 2025
4. Updates in Surgery — Efficacy of Oral Neomycin and Bacitracin in Reducing Surgical Site Infections Following Elective Colorectal Surgery: Results from the COLORAL-1 Multicenter, Randomized, Parallel, Single-Blind Study
5. Impact of Immunonutrition on Surgical Outcomes in Colorectal Cancer Patients: A Meta-Analytic Review
6. Improvements in Surgical Protocols Decrease Incidence of Anastomotic Leakage Following Colorectal Resection Procedures
7. Guidelines for preoperative care in elective colorectal surgery: ERAS Society recommendations 2025 - ERAS® Society
8. Do Perioperative Probiotics/Synbiotics Reduce Postoperative Infection Rates Following Elective Colorectal Surgery? A Systematic Review and Meta-Analysis - ScienceDirect
9. [Expert consensus on the diagnosis and treatment of low anterior resection syndrome (2025 edition)] - PubMed