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Clinical Efficacy of Sodium Butyrate in Managing Pediatric Inflammatory Bowel Disease
Adrian Goldiș1, Radu Dragomir2, Marina Adriana Mercioni3,4
1Department of Gastroenterology and Hepatology, "Victor Babeș" University of Medicine and Pharmacy, 300041 Timișoara, Romania.
Insights
Sodium butyrate supplementation effectively treated pediatric inflammatory bowel disease (IBD) in a 12-week trial. This treatment significantly reduced disease activity and inflammation markers in children and adolescents with IBD.
Area of Science:
- Gastroenterology
- Pediatric Medicine
- Nutritional Science
Background:
- Limited research exists on butyric acid's efficacy for pediatric inflammatory bowel disease (IBD).
- Inflammatory bowel disease (IBD) affects children and adolescents, necessitating effective treatment strategies.
Purpose of the Study:
- To evaluate oral sodium butyrate (MSB®) as an adjunct therapy for newly diagnosed pediatric IBD patients.
- To assess the impact of sustained-release sodium butyrate on disease activity and inflammatory markers in children with IBD.
Main Methods:
- A unicentric, prospective, randomized, placebo-controlled trial involving 88 pediatric patients (7-18 years) with ulcerative colitis or Crohn's disease.
- Patients received either 150 mg daily sodium butyrate (Group A) or a placebo (Group B) alongside conventional treatment for 12 weeks.
- Primary outcomes included disease activity, C-reactive protein (CRP), and fecal calprotectin levels at 12 weeks.
Main Results:
- 81.82% of patients in the sodium butyrate group achieved remission compared to 47.73% in the placebo group (p < 0.001).
- Significantly lower CRP levels (18.14 ± 11.19 mg/L vs. 57.00 ± 33.28 mg/L) and reduced fecal calprotectin were observed in the sodium butyrate group (p < 0.001).
- No adverse effects were reported in either group.
Conclusions:
- A 12-week course of sodium butyrate supplementation demonstrated significant efficacy as an adjunctive treatment for newly diagnosed pediatric IBD.
- Sodium butyrate effectively reduced disease activity and intestinal inflammation in children and adolescents with IBD.
- Oral sodium butyrate is a safe and effective therapeutic option for managing pediatric inflammatory bowel disease.
Background:
Few studies have evaluated the efficacy of butyric acid in treating children with inflammatory bowel disease (IBD). In children and adolescents with recently diagnosed IBD, the purpose of this research was to assess the efficacy of oral sodium butyrate (the product-patented, sustained and targeted-release form of butyrate MSB®) as an adjunct to conventional treatment.
Methods:
This trial was unicentric, prospective, randomized, and placebo-controlled. An amount of 150 mg sodium butyrate once a day (Group A), or a placebo (Group B) were randomly assigned to patients with ulcerative colitis or Crohn's disease, aged 7-18 years, who were receiving conventional medication based on the severity of their conditions. Disease activity, C-reactive protein (CRP), and fecal calprotectin concentration differences between the two study groups at 12 weeks of the trial were the main outcomes.
Results:
With 44 patients in Group A and 44 in Group B, 88 individuals with initially active illness finished the research. Most patients experienced remission by week 12 of the study (36 patients in Group A with sodium butyrate, 81.82%; 21 patients in Group B with placebo, 47.73%). Between the two groups, a significant difference in disease activity was seen (p < 0.001). The sodium butyrate group appeared to have less systemic inflammation than the other group, as evidenced by the significantly lower CRP levels in Group A (18.14 ± 11.19 mg/L) compared to Group B (57.00 ± 33.28 mg/L) at 12 weeks (T2) (p < 0.001). No negative effects were recorded by any of the patients. Fecal calprotectin in Group A dropped much more after 12 weeks (T2) (p < 0.001), suggesting that the sodium butyrate group was better able to regulate intestinal inflammation.
Conclusions:
In newly diagnosed children and adolescents with IBD, a 12-week sodium butyrate supplementation did demonstrate effectiveness as an additional treatment.
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