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Completed

NCT Number: NCT05456763

Butyrate in Pediatric Inflammatory Bowel Disease

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.

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sodium Butyrate

Dietary Supplement

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

Placebo

Other

placebo

Primary outcomes

  1. difference in remission rate (PCDAI for Crohn's disease)

    Time frame: 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.

  2. difference in remission rate (PUCAI ulcerative colitis)

    Time frame: 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 outcomes

  1. difference in disease activity for CD and UC patients

    Time frame: 12 weeks

    assessed separately, calcultated in points (described above)

  2. difference in calprotectin concentration

    Time frame: 12 weeks

    measured in µg/g assessed in different soubgroups (lower result is better, remission = less than 50.

  3. side effects

    Time frame: 12 weeks

    assessed for both groups (descriptive)

Sponsors and collaborators

Lead sponsor

Centre of Postgraduate Medical Education

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2022
First posted
Jul 13, 2022
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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