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

Abstract

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.

Keywords: irritable bowel syndrome; microencapsulated sodium butyrate; prebiotics; probiotics; synbiotics.

Figure 1

Study flowchart.

Figure 2

Percentage of patients with an improvement in IBS symptoms as measured by the IBS-SSS at week (w) 4, 8, and 12. Black bars—biotic group, grey bars—placebo group. (A)—total IBS-SSS score; (B)—abdominal pain intensity (IBS-SSS1 score); (C) days with pain (IBS-SSS2 score); (D)—intensity of flatulence (IBS-SSS3 score); (E)—dissatisfaction with bowels (IBS-SSS4 score); (F)—quality of life (IBS-SSS4 score).

Figure 3

The effect of intervention on global IBS symptoms as measured by the IBS-GIS. The results are presented as (A)—percentage of patients reporting an improvement of symptoms (assessed as 5–7 points) and (B)—percentage of patients reporting worsening of symptoms (assessed as 1–3 points). Black bars—biotic group, grey bars—placebo group; * p < 0.05.

Figure 4

The effect of intervention on patient-recorded symptom scales (5-point Likert). Baseline = one week observation before intervention. Results are presented as change from baseline in means ± SD scores (A–C) or change from baseline in % of patients who reported ‘feeling of incomplete evacuation after bowel movement’ (D) in each week. * p < 0.05 between the study groups; # p < 0.05 within the biotic group when compared with baseline; § p < 0.05 within the placebo group when compared with baseline.