Efficacy and Safety of a Mixture of Microencapsulated Sodium Butyrate, Probiotics, and Short Chain Fructooligosaccharides in Patients with Irritable Bowel Syndrome-A Randomized, Double-Blind, Placebo-Controlled Study.

Objective: Biotics are increasingly being used in the treatment of irritable bowel syndrome (IBS). This study aimed to assess the efficacy and safety of a mixture of microencapsulated sodium butyrate, probiotics (Lactocaseibacillus rhamnosus DSM 26357, Lactobacillus acidophilus DSM 32418, Bifidobacterium longum DSM 32946, Bifidobacterium bifidum DSM 32403, and Bifidobacterium lactis DSM 32269), and short-chain fructooligosaccharides (scFOSs) in IBS patients. Methods: This was a randomized, double-blind, placebo-controlled trial involving 120 adult participants with IBS. The primary outcome of the 12-week intervention was the improvement in IBS symptoms and quality of life (QOL), assessed with the use of IBS-Adequate Relief (IBS-AR), IBS-Global Improvement Scale (IBS-GIS), IBS-Symptom Severity Score (IBS-SSS), and IBS-QOL. Secondary outcomes were the number and type of stools (assessed via the Bristol Stool Form scale), patient-recorded symptoms, anthropometric parameters, and levels of selected inflammatory cytokines. Results: As early as at 4 weeks, there was a higher percentage of patients in the biotic group reporting adequate relief of symptoms (based on IBS-AR) than in the placebo group (64.7% vs. 42.0%, respectively, p = 0.023). At 12 weeks, fewer patients in the biotic group reported a 'worsening of symptoms' (based on IBS-GIS) than in the placebo group (5.9% vs. 16.0% respectively, p = 0.015). There were no significant differences between groups in IBS-QOL or IBS-SSS or any of the secondary outcome measures except the patient-recorded 'urgency to defecate' (p = 0.015) at week 12, which was significantly lower in the biotic group. The intervention was safe and well tolerated. Conclusions: A biotic mixture consisting of microencapsulated butyrate, probiotics, and small amounts of scFOSs is safe and effective in improving gastrointestinal symptoms in patients with IBS.