Butyrate in Pediatric Inflammatory Bowel Disease

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Dietary Supplement: sodium butyrate
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in disease activity for CD and UC patients | assessed separately, calcultated in points (described above) | 12 weeks | 
| difference in calprotectin concentration | measured in µg/g assessed in different soubgroups (lower result is better, remission = less than 50. | 12 weeks | 
| side effects | assessed for both groups (descriptive) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease, ulcerative colitis, sodium butyrate