Clinical Efficacy of Sodium Butyrate in Managing Pediatric Inflammatory Bowel Disease

Background: Few studies have evaluated the efficacy of butyric acid in treating children with inflammatory bowel disease (IBD). In children and adolescents with recently diagnosed IBD, the purpose of this research was to assess the efficacy of oral sodium butyrate (the product-patented, sustained and targeted-release form of butyrate MSB (R)) as an adjunct to conventional treatment. Methods: This trial was unicentric, prospective, randomized, and placebo-controlled. An amount of 150 mg sodium butyrate once a day (Group A), or a placebo (Group B) were randomly assigned to patients with ulcerative colitis or Crohn's disease, aged 7-18 years, who were receiving conventional medication based on the severity of their conditions. Disease activity, C-reactive protein (CRP), and fecal calprotectin concentration differences between the two study groups at 12 weeks of the trial were the main outcomes. Results: With 44 patients in Group A and 44 in Group B, 88 individuals with initially active illness finished the research. Most patients experienced remission by week 12 of the study (36 patients in Group A with sodium butyrate, 81.82%; 21 patients in Group B with placebo, 47.73%). Between the two groups, a significant difference in disease activity was seen (p < 0.001). The sodium butyrate group appeared to have less systemic inflammation than the other group, as evidenced by the significantly lower CRP levels in Group A (18.14 +/- 11.19 mg/L) compared to Group B (57.00 +/- 33.28 mg/L) at 12 weeks (T2) (p < 0.001). No negative effects were recorded by any of the patients. Fecal calprotectin in Group A dropped much more after 12 weeks (T2) (p < 0.001), suggesting that the sodium butyrate group was better able to regulate intestinal inflammation. Conclusions: In newly diagnosed children and adolescents with IBD, a 12-week sodium butyrate supplementation did demonstrate effectiveness as an additional treatment.