Butyrate in Pediatric Inflammatory Bowel Disease

Centre of Postgraduate Medical Education

Status

Completed

Conditions

Inflammatory Bowel Diseases

Treatments

Other: placebo

Dietary Supplement: sodium butyrate

Study type

Interventional

Funder types

Other

Identifiers

NCT05456763

nr 41/2013

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

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.