Butyrate in Pediatric Inflammatory Bowel Disease

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05456763
• Other study ID #: nr 41/2013
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: June 2022

Study information

• Verified date: July 2022
• Source: Centre of Postgraduate Medical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2022
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Dietary Supplement:
• sodium butyrate
add-on therapy irrespective of standard treatment depending on severity (according to the guidelines)

Other:
• placebo
placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre of Postgraduate Medical Education

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in remission rate (PCDAI for Crohn's disease)	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.	12 weeks
Primary	difference in remission rate (PUCAI ulcerative colitis)	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.	12 weeks
Secondary	difference in disease activity for CD and UC patients	assessed separately, calcultated in points (described above)	12 weeks
Secondary	difference in calprotectin concentration	measured in µg/g assessed in different soubgroups (lower result is better, remission = less than 50.	12 weeks
Secondary	side effects	assessed for both groups (descriptive)	12 weeks