Butyrate in Pediatric Inflammatory Bowel Disease

Sponsor

Centre of Postgraduate Medical Education (Other)

Overall Status

Completed

CT.gov ID

NCT05456763

Collaborator

(none)

100

Enrollment

Arms

108

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases	Dietary Supplement: sodium butyrate Other: placebo	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group A 150 mg sodium butyrate twice a day for 12 weeks	Dietary Supplement: sodium butyrate add-on therapy irrespective of standard treatment depending on severity (according to the guidelines)
Placebo Comparator: group B placebo capsules twice a day for 12 weeks	Other: placebo placebo

Arm

Intervention/Treatment

Experimental: group A

150 mg sodium butyrate twice a day for 12 weeks

Dietary Supplement: sodium butyrate

add-on therapy irrespective of standard treatment depending on severity (according to the guidelines)

Placebo Comparator: group B

placebo capsules twice a day for 12 weeks

Other: placebo

placebo

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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.