Effects of Butyrate Supplementation on Inflammation and Kidney Parameters in Type 1 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Trial

Randomized, double-blind, placebo-controlled trial in adults with type 1 diabetes, albuminuria, and intestinal inflammation. In the sodium butyrate group, 28 participants were randomized; the study was conducted at Steno Diabetes Center Copenhagen in Denmark and Folkhälsan Research Center in Helsinki, Finland.

Oral sodium butyrate was given at 3.6 g/day for 12 weeks, delivered as delayed-release capsules with sodium alginate. The regimen was 1.8 g per dose (six capsules) twice daily and was compared with placebo.

Sodium butyrate did not improve intestinal inflammation, kidney parameters, glycemic control, or other measured biomarkers versus placebo. Fecal calprotectin did not differ significantly at 12 weeks (ANCOVA p = 0.24), and urinary albumin-creatinine ratio (p = 0.69), estimated glomerular filtration rate (p = 0.30), hs-CRP (p = 0.13), serum lipopolysaccharide (p = 0.093), and HbA1c (p = 0.32) were also not significantly changed. Other fecal markers, including IAP activity/protein, fecal butyrate, acetate, propionate, valerate, and immunoglobulins, were likewise not significantly different. The authors concluded that 12 weeks of butyrate at the tested dose did not reduce intestinal inflammation or improve related outcomes in this population.

The trial was relatively small and short, which limits power to detect modest effects and longer-term renal or metabolic changes. Multiple endpoints were assessed, but no meaningful benefit emerged, and safety-event attribution by arm was incomplete for some serious adverse events. Generalizability is limited to adults with type 1 diabetes, albuminuria, and elevated fecal calprotectin treated with this specific delayed-release sodium butyrate regimen.