Butyrate in Pediatric Inflammatory Bowel Disease
- Conditions
- Inflammatory Bowel Diseases
- Interventions
- Dietary Supplement: sodium butyrateOther: placebo
- Registration Number
- NCT05456763
- Lead Sponsor
- Centre of Postgraduate Medical Education
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group A sodium butyrate 150 mg sodium butyrate twice a day for 12 weeks group B placebo placebo capsules twice a day for 12 weeks
- Primary Outcome Measures
Name Time Method difference in remission rate (PUCAI ulcerative colitis) 12 weeks The Pediatric Ulcerative Colitis Activity Index (PUCAI) measured in points of activity was used to assess UC activity.
Severity of the disease:
\<10 points = remission 10-34 points = mild ulcerative colitis 35-64 points = moderate ulcerative colitis
≥65 points = severe ulcerative colitis
In this scale addominal pain (mild or moderate/severe), number of stools per day, blood in the stool, stool consistency, nocturnal stools and activity level (no limitation, occasional or restricted), are assessed. The scale is validated and used in daily clinical practice.
Remission was defined as less than 10 points for both PCDAI and PUCAI scores.difference in remission rate (PCDAI for Crohn's disease) 12 weeks The Pediatric Crohn's Disease Activity Index (PCDAI) measured in points of activity was used to assess CD activity.
Severity of the disease:
\<10 points = remission 10-27.5 points = mild Crohn's Disease 30-37.5 points = moderate Crohn's Disease
≥40 points = severe Crohn's Disease
In this scale addominal pain (mild or moderate/severe), number of stools per day, general well being (good, below par, very poor), antropometric measures, palpable mass in the abdomen and perianal fistulas are assessed. The scale is validated and used in daily clinical practice.
Remission was defined as less than 10 points for both PCDAI and PUCAI scores.
- Secondary Outcome Measures
Name Time Method difference in disease activity for CD and UC patients 12 weeks assessed separately, calcultated in points (described above)
difference in calprotectin concentration 12 weeks measured in µg/g assessed in different soubgroups (lower result is better, remission = less than 50.
side effects 12 weeks assessed for both groups (descriptive)