Safety and Preliminary Clinical Outcomes of a Combined Cannabidiol and Sodium Propionate Enema in Refractory Ulcerative Proctitis: An Open-Label Pilot Study.

Introduction: Patients with ulcerative proctitis who fail 5-aminosalicylic acid therapy often escalate to systemic immunosuppressants or biologics, which carry significant risks. IcBD-01 is a novel enema combining cannabidiol and sodium propionate, formulated to deliver local anti-inflammatory effects with minimal systemic exposure. This proof-of-concept study assessed the safety, tolerability, and preliminary efficacy of IcBD-01 in patients with mild to moderate ulcerative proctitis. Methods: Fourteen patients unresponsive to ≥3 months of mesalamine were enrolled in a prospective, open-label, single-arm 12-week trial. IcBD-01 was self-administered daily. Disease activity was assessed using the Mayo score, patient-reported outcomes (PROs), endoscopy, histology, and inflammatory markers. Results: Of 14 enrolled patients, 9 completed the study and 10 completed ≥10 weeks of treatment. In the intention-to-treat analysis, 50% met the primary endpoint (≥3-point Mayo score reduction); in the per-protocol analysis, 77% achieved this. Full Mayo scores improved from 6.8 ± 1.7 to 3.0 ± 2.5 ( Conclusion: In this open-label, proof-of-concept study, IcBD-01 was well tolerated and associated with clinically meaningful improvements. These hypothesis-generating findings warrant further evaluation in randomized, placebo-controlled trials.