Butyrate in Pediatric Inflammatory Bowel Disease

Sodium Butyrate Effectiveness in Children and Adolescents With Newly Diagnosed Inflammatory Bowel Diseases - Randomized Placebo-controlled Multicentre Trial

The first prospective randomised placebo-controlled study in the IBD pediatric population was conducted to evaluate the effectiveness of oral sodium butyrate as add-on therapy in IBD.

Butyric acid's effectiveness has not yet been assessed in the pediatric inflammatory bowel disease (IBD) population. This study aimed to evaluate the effectiveness of oral sodium butyrate as an add-on to standard therapy in children and adolescents with newly diagnosed IBD.

This was a prospective, randomized, placebo-controlled multicentre study. Patients aged 6-18 years with colonic Crohn's disease or ulcerative colitis, who received standard therapy depending on the disease's severity, were randomized to receive 150 mg sodium butyrate twice a day (group A) or placebo (group B). The primary outcome was the difference in disease activity and fecal calprotectin concentration between the two study groups measured at 12 weeks of the study.

Inclusion Criteria:

• 6 to 18 years of age;
• newly diagnosed, based on the modified Porto criteria, IBD with colon involvement;
• informed consent of the child's parents or guardians to participate in the study.

Exclusion Criteria:

• age <6 years;
• taking probiotics or dietary supplements in the last 2 weeks prior to study enrollment;
• lack of consent of parents or guardians to participate in the study.