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Sodium Butyrate Effectiveness in Children and Adolescents with Newly Diagnosed Inflammatory Bowel Diseases-Randomized
Anna Pietrzak1,2, Marcin Banasiuk3, Mariusz Szczepanik4
1II Gastroenterology Department, Centre of Postgraduate Medical Education, 01-813 Warsaw, Poland.
Insights
Oral sodium butyrate did not improve remission rates or disease activity in children and adolescents with newly diagnosed inflammatory bowel disease (IBD) when used as an add-on therapy. The 12-week study found no significant differences between the sodium butyrate and placebo groups.
Area of Science:
- Gastroenterology
- Pediatric Medicine
- Clinical Nutrition
Background:
- The efficacy of butyric acid, a short-chain fatty acid, remains unevaluated in pediatric inflammatory bowel disease (IBD).
- Inflammatory bowel disease (IBD) encompasses chronic conditions like Crohn's disease and ulcerative colitis affecting the gastrointestinal tract.
Purpose of the Study:
- To assess the effectiveness of oral sodium butyrate as an adjunct to standard treatment in pediatric patients with newly diagnosed IBD.
- To determine if sodium butyrate supplementation impacts disease activity and inflammatory markers in children and adolescents with IBD.
Main Methods:
- A prospective, randomized, placebo-controlled, multicenter trial was conducted.
- Participants aged 6-18 years with active colonic Crohn's disease or ulcerative colitis received standard therapy plus either 150 mg sodium butyrate twice daily or a placebo for 12 weeks.
- Disease activity and fecal calprotectin levels were primary outcome measures at 12 weeks.
Main Results:
- 72 patients completed the study; 29 received sodium butyrate and 43 received placebo.
- A majority of patients in both groups achieved remission by week 12.
- No statistically significant differences were observed in remission rates (p=0.37) or median disease activity (p=0.31) between the sodium butyrate and placebo groups.
- No adverse events were reported by any participants.
Conclusions:
- Twelve-week adjunctive therapy with sodium butyrate demonstrated no significant efficacy in newly diagnosed pediatric IBD patients.
- Oral sodium butyrate supplementation is not effective in improving clinical outcomes or reducing inflammation in this population.
- Further research may be needed to explore alternative therapeutic roles or formulations of butyric acid in IBD management.
Background:
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.
Methods:
This was a prospective, randomized, placebo-controlled multicenter 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.
Results:
In total, 72 patients with initially active disease completed the study, 29 patients in group A and 43 in group B. At week 12 of the study, the majority of patients achieved remission. No difference in remission rate or median disease activity was found between the two groups (p = 0.37 and 0.31, respectively). None of the patients reported adverse events.
Conclusions:
A 12-week supplementation with sodium butyrate, as adjunctive therapy, did not show efficacy in newly diagnosed children and adolescents with IBD.
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