Inflammatory Bowel Diseases
Conditions
Keywords
Crohn's disease, ulcerative colitis, sodium butyrate
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.
Interventions
DIETARY_SUPPLEMENTsodium butyrate
add-on therapy irrespective of standard treatment depending on severity (according to the guidelines)
OTHERplacebo
placebo
Sponsors
Centre of Postgraduate Medical Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Outcome results
None listed