Efficacy of Microencapsulated Sodium Butyrate as Add-On Therapy in Inducing Remission in Patients with Mild-To-Moderate Ulcerative Colitis: Results From a Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study.

BACKGROUND Microencapsulated sodium butyrate (MSB) is a colon-targeted form of butyric acid with anti-inflammatory and mucosal healing properties. This study evaluated its efficacy and safety as add-on therapy for inducing remission in patients with mild-to-moderate ulcerative colitis (UC). MATERIAL AND METHODS In this multi-center, double-blind, randomized, placebo-controlled trial, 98 adults with active mild-to-moderate UC received either MSB (2×300 mg/day) or placebo for 8 weeks. Primary endpoints included clinical improvement (≥3-point reduction in Total Mayo Score [TMS]), clinical remission (TMS ≤2, rectal bleeding subscore=0, stool frequency ≤1), endoscopic improvement (≥1-point reduction), endoscopic remission (Mayo score=0), and biochemical remission (fecal calprotectin ≤250 µg/g). Secondary endpoints were changes in fecal butyric acid (C4) and selected laboratory markers. RESULTS In the MSB group, 26 patients (51%) showed clinical improvement (P=0.005), 16 (31.4%) achieved clinical remission (P=0.004), and 21 (42.2%) reached biochemical remission (P=0.009). Additionally, 12 patients (25.5%) demonstrated endoscopic improvement (P=0.006). Among those in clinical remission, there was a strong positive correlation between changes in C4 and TMS (rho=0.80, P=0.003) and MS change (rho=0.87, P=0.001). A strong positive correlation was also observed between C4 levels at Visit 2 and MS change (rho=0.71, P=0.014). CONCLUSIONS MSB is a safe and effective adjunct therapy for mild-to-moderate UC, leading to clinical improvement, remission, and endoscopic improvement. Further studies are warranted to assess the effects of longer MSB administration on mucosal healing.