NCT05456763

Butyrate in Pediatric Inflammatory Bowel Disease

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Centre of Postgraduate Medical Education · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	sodium butyrate	add-on therapy irrespective of standard treatment depending on severity (according to the guidelines)
OTHER	placebo	placebo

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-02-01
• Completion: 2022-06-01
• First posted: 2022-07-13
• Last updated: 2022-07-13